Job Summary
Sell priority products in order to meet and exceed annual sales quotas by using the Account Call Model.
Exceptional delivery of all core arguments and associated product messages.
Consistent, excellent implementation of the Sales Action Plan.
Communication, coordination and cooperation with fellow representatives, specialty representatives and all of Company Management.
Plan and allocate sales activities to the highest potential opportunities to drive results for both the Public and Private markets.
Continually gain rapport with increasing number of customers by utilizing professional communication skills.
Use consultative selling approaches that satisfy the Company's various customers’ styles and business/product needs.
Routinely service and follow up with customers on product purchases and practices.
Prospect and qualify new and emerging markets and feedback information to the Company as requested.
Operate within assigned budgets.
Strong oral, written and analytical skills with the demonstrated ability to work in teams.
Strong time management skills
Basic Qualifications
B.A. /B.S. required, preferably in the field of Immunology, Biology or Business.
2 years business to business sales experience.
A valid driver's license is required along with a record of safe driving
Apr 02, 2020
Job Summary
Sell priority products in order to meet and exceed annual sales quotas by using the Account Call Model.
Exceptional delivery of all core arguments and associated product messages.
Consistent, excellent implementation of the Sales Action Plan.
Communication, coordination and cooperation with fellow representatives, specialty representatives and all of Company Management.
Plan and allocate sales activities to the highest potential opportunities to drive results for both the Public and Private markets.
Continually gain rapport with increasing number of customers by utilizing professional communication skills.
Use consultative selling approaches that satisfy the Company's various customers’ styles and business/product needs.
Routinely service and follow up with customers on product purchases and practices.
Prospect and qualify new and emerging markets and feedback information to the Company as requested.
Operate within assigned budgets.
Strong oral, written and analytical skills with the demonstrated ability to work in teams.
Strong time management skills
Basic Qualifications
B.A. /B.S. required, preferably in the field of Immunology, Biology or Business.
2 years business to business sales experience.
A valid driver's license is required along with a record of safe driving
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Sanofi Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on specialty areas including: immunology, oncology and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi Genzyme's portfolio of transformative therapies, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Sanofi Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.
At Sanofi Genzyme, we are committed to the growth of our people, connected in purpose by career, life and health.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Apr 02, 2020
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Sanofi Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on specialty areas including: immunology, oncology and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi Genzyme's portfolio of transformative therapies, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Sanofi Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.
At Sanofi Genzyme, we are committed to the growth of our people, connected in purpose by career, life and health.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities.
The Entry Level Chronic Care Representative (CCR) is the primary point of contact for a variety of customers within their assigned geography.
These customers may include: health care providers such as physicians, physician assistants, nurse practitioners, nurses, pharmacists as well as quality directors and office managers. Within their geography there are a diverse set of health care locations that they will call upon in order to execute their role including: physicians’ offices, integrated delivery systems, and hospital clinics.
The Chronic Care Representative is a key member of the local Customer Team that works collaboratively with other Company field-based employees such as the Account Executives, Integration Delivery Systems leaders as well as other members of the extended team.
The primary activities include:
Developing a territory level business plan in accordance with our Company’s policies, standards, and ethics.
Maintaining product knowledge and certification on our Company’s portfolio for which they are responsible.
Engaging in balanced product sales discussions with Health Care Providers and Health Care Business Professionals to align customer needs and Company products in accordance with product labeling. This is achieved by keeping apprised of professional and health care environment knowledge through self-study of company-provided scientific, product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of Company promotional materials
Providing our Company management with updates on customer needs as it relates to helping them improve patient health outcomes, customer feedback, marketplace dynamics, and progress towards quality goals.
Providing customers with key insights by keeping apprised of professional and health care environment knowledge through self-study of company-provided scientific, product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of our companies promotional materials.
Regularly monitoring their business performance against objectives using company provided tools.
Education Minimum Requirement:
BA/BS
Required Experience and Skills:
Demonstrated excellence in current or previous educational or professional roles
Excellent interpersonal and communication skills
Ability to work both independently and within a team environment
Strong organizational and time management skills
Valid Driver's license
Preferred Experience and Skills:
Ability to convey technical concepts accurately and clearly
Previous sales, account management, consultative, or customer service experience
Ability to analyze metrics to assess progress against objectives
Apr 01, 2020
Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities.
The Entry Level Chronic Care Representative (CCR) is the primary point of contact for a variety of customers within their assigned geography.
These customers may include: health care providers such as physicians, physician assistants, nurse practitioners, nurses, pharmacists as well as quality directors and office managers. Within their geography there are a diverse set of health care locations that they will call upon in order to execute their role including: physicians’ offices, integrated delivery systems, and hospital clinics.
The Chronic Care Representative is a key member of the local Customer Team that works collaboratively with other Company field-based employees such as the Account Executives, Integration Delivery Systems leaders as well as other members of the extended team.
The primary activities include:
Developing a territory level business plan in accordance with our Company’s policies, standards, and ethics.
Maintaining product knowledge and certification on our Company’s portfolio for which they are responsible.
Engaging in balanced product sales discussions with Health Care Providers and Health Care Business Professionals to align customer needs and Company products in accordance with product labeling. This is achieved by keeping apprised of professional and health care environment knowledge through self-study of company-provided scientific, product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of Company promotional materials
Providing our Company management with updates on customer needs as it relates to helping them improve patient health outcomes, customer feedback, marketplace dynamics, and progress towards quality goals.
Providing customers with key insights by keeping apprised of professional and health care environment knowledge through self-study of company-provided scientific, product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of our companies promotional materials.
Regularly monitoring their business performance against objectives using company provided tools.
Education Minimum Requirement:
BA/BS
Required Experience and Skills:
Demonstrated excellence in current or previous educational or professional roles
Excellent interpersonal and communication skills
Ability to work both independently and within a team environment
Strong organizational and time management skills
Valid Driver's license
Preferred Experience and Skills:
Ability to convey technical concepts accurately and clearly
Previous sales, account management, consultative, or customer service experience
Ability to analyze metrics to assess progress against objectives
The Medical Sales Professional (MSP) is responsible for growing, managing, developing, and representing Lemborexant in their respected territory. The MSP is the territory business owner responsible for creating strategies and executing tactics to generate product utilization that consistently achieve sales goals while conveying Eisai’s human health care mission (hhc). The Medical Sales Professional will be required to be an expert on all aspects of the insomnia, our product, and the competitive landscape, including coverage and reimbursement. They will build and develop professional relationships with appropriate HCPs and other healthcare professionals and office staff, and be expected to work cross-functionally while adhering to all of Eisai’s ethics and compliance standards.
Essential Functions 1. Achieve sales goals and drive appropriate utilization of assigned products through effective use of the Challenger Sales model, creating and maintaining an effective plan, and precise execution of sales and brand strategies; including effective and compliant utilization of available resources (i.e. approved sales aids and materials, educational lunches, speaker programs). 2. Collaborate with the Eisai team, including other field-based and home office personnel teams to proactively develop strategies that address customer needs, local market dynamics and trends, and support brand and corporate objectives within assigned geography. Includes participating in initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). 3. Develop deep knowledge of insomnia industry, local and regional market trends, disease state, product, and competitor knowledge. Leverage expertise and knowledge to anticipate and effectively manage business opportunities and challenges with HCPs in assigned geography (75-80% of targets will be General Practitioners and Family Medicine.) 4. Ensure individual compliance with Eisai policies and procedures.
Qualifications
Requirements •Bachelor’s degree required •2 or more years of pharmaceutical sales experience, strongly preferred •A minimum of 3 years of business-to-business sales experience, required •Strong business acumen •Demonstrated ability to establish and maintain strong business relationships. Proven ability to network and build strong relationships with customers •Valid US driver’s license and a driving record in compliance with company standards •Ability to safely and successfully operate a motor vehicle is required •Must successfully complete all company training programs and pass the company certification process, as well as all customer mandated and vendor credentialing requirements. •Strong verbal and written communication skills •Strong negotiating skills •Effective consultative selling skills •When necessary, travel overnight including within territory and to conferences, training and sales meetings.
Mar 31, 2020
The Medical Sales Professional (MSP) is responsible for growing, managing, developing, and representing Lemborexant in their respected territory. The MSP is the territory business owner responsible for creating strategies and executing tactics to generate product utilization that consistently achieve sales goals while conveying Eisai’s human health care mission (hhc). The Medical Sales Professional will be required to be an expert on all aspects of the insomnia, our product, and the competitive landscape, including coverage and reimbursement. They will build and develop professional relationships with appropriate HCPs and other healthcare professionals and office staff, and be expected to work cross-functionally while adhering to all of Eisai’s ethics and compliance standards.
Essential Functions 1. Achieve sales goals and drive appropriate utilization of assigned products through effective use of the Challenger Sales model, creating and maintaining an effective plan, and precise execution of sales and brand strategies; including effective and compliant utilization of available resources (i.e. approved sales aids and materials, educational lunches, speaker programs). 2. Collaborate with the Eisai team, including other field-based and home office personnel teams to proactively develop strategies that address customer needs, local market dynamics and trends, and support brand and corporate objectives within assigned geography. Includes participating in initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). 3. Develop deep knowledge of insomnia industry, local and regional market trends, disease state, product, and competitor knowledge. Leverage expertise and knowledge to anticipate and effectively manage business opportunities and challenges with HCPs in assigned geography (75-80% of targets will be General Practitioners and Family Medicine.) 4. Ensure individual compliance with Eisai policies and procedures.
Qualifications
Requirements •Bachelor’s degree required •2 or more years of pharmaceutical sales experience, strongly preferred •A minimum of 3 years of business-to-business sales experience, required •Strong business acumen •Demonstrated ability to establish and maintain strong business relationships. Proven ability to network and build strong relationships with customers •Valid US driver’s license and a driving record in compliance with company standards •Ability to safely and successfully operate a motor vehicle is required •Must successfully complete all company training programs and pass the company certification process, as well as all customer mandated and vendor credentialing requirements. •Strong verbal and written communication skills •Strong negotiating skills •Effective consultative selling skills •When necessary, travel overnight including within territory and to conferences, training and sales meetings.
The Medical Sales Professional (MSP) is responsible for growing, managing, developing, and representing Lemborexant in their respected territory. The MSP is the territory business owner responsible for creating strategies and executing tactics to generate product utilization that consistently achieve sales goals while conveying Eisai’s human health care mission (hhc). The Medical Sales Professional will be required to be an expert on all aspects of the insomnia, our product, and the competitive landscape, including coverage and reimbursement. They will build and develop professional relationships with appropriate HCPs and other healthcare professionals and office staff, and be expected to work cross-functionally while adhering to all of Eisai’s ethics and compliance standards.
Essential Functions 1. Achieve sales goals and drive appropriate utilization of assigned products through effective use of the Challenger Sales model, creating and maintaining an effective plan, and precise execution of sales and brand strategies; including effective and compliant utilization of available resources (i.e. approved sales aids and materials, educational lunches, speaker programs). 2. Collaborate with the Eisai team, including other field-based and home office personnel teams to proactively develop strategies that address customer needs, local market dynamics and trends, and support brand and corporate objectives within assigned geography. Includes participating in initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). 3. Develop deep knowledge of insomnia industry, local and regional market trends, disease state, product, and competitor knowledge. Leverage expertise and knowledge to anticipate and effectively manage business opportunities and challenges with HCPs in assigned geography (75-80% of targets will be General Practitioners and Family Medicine.) 4. Ensure individual compliance with Eisai policies and procedures.
Qualifications
Requirements •Bachelor’s degree required •2 or more years of pharmaceutical sales experience, strongly preferred •A minimum of 3 years of business-to-business sales experience, required •Strong business acumen •Demonstrated ability to establish and maintain strong business relationships. Proven ability to network and build strong relationships with customers •Valid US driver’s license and a driving record in compliance with company standards •Ability to safely and successfully operate a motor vehicle is required •Must successfully complete all company training programs and pass the company certification process, as well as all customer mandated and vendor credentialing requirements. •Strong verbal and written communication skills •Strong negotiating skills •Effective consultative selling skills •When necessary, travel overnight including within territory and to conferences, training and sales meetings.
Mar 31, 2020
The Medical Sales Professional (MSP) is responsible for growing, managing, developing, and representing Lemborexant in their respected territory. The MSP is the territory business owner responsible for creating strategies and executing tactics to generate product utilization that consistently achieve sales goals while conveying Eisai’s human health care mission (hhc). The Medical Sales Professional will be required to be an expert on all aspects of the insomnia, our product, and the competitive landscape, including coverage and reimbursement. They will build and develop professional relationships with appropriate HCPs and other healthcare professionals and office staff, and be expected to work cross-functionally while adhering to all of Eisai’s ethics and compliance standards.
Essential Functions 1. Achieve sales goals and drive appropriate utilization of assigned products through effective use of the Challenger Sales model, creating and maintaining an effective plan, and precise execution of sales and brand strategies; including effective and compliant utilization of available resources (i.e. approved sales aids and materials, educational lunches, speaker programs). 2. Collaborate with the Eisai team, including other field-based and home office personnel teams to proactively develop strategies that address customer needs, local market dynamics and trends, and support brand and corporate objectives within assigned geography. Includes participating in initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). 3. Develop deep knowledge of insomnia industry, local and regional market trends, disease state, product, and competitor knowledge. Leverage expertise and knowledge to anticipate and effectively manage business opportunities and challenges with HCPs in assigned geography (75-80% of targets will be General Practitioners and Family Medicine.) 4. Ensure individual compliance with Eisai policies and procedures.
Qualifications
Requirements •Bachelor’s degree required •2 or more years of pharmaceutical sales experience, strongly preferred •A minimum of 3 years of business-to-business sales experience, required •Strong business acumen •Demonstrated ability to establish and maintain strong business relationships. Proven ability to network and build strong relationships with customers •Valid US driver’s license and a driving record in compliance with company standards •Ability to safely and successfully operate a motor vehicle is required •Must successfully complete all company training programs and pass the company certification process, as well as all customer mandated and vendor credentialing requirements. •Strong verbal and written communication skills •Strong negotiating skills •Effective consultative selling skills •When necessary, travel overnight including within territory and to conferences, training and sales meetings.
The Medical Sales Professional (MSP) is responsible for growing, managing, developing, and representing Lemborexant in their respected territory. The MSP is the territory business owner responsible for creating strategies and executing tactics to generate product utilization that consistently achieve sales goals while conveying Eisai’s human health care mission (hhc). The Medical Sales Professional will be required to be an expert on all aspects of the insomnia, our product, and the competitive landscape, including coverage and reimbursement. They will build and develop professional relationships with appropriate HCPs and other healthcare professionals and office staff, and be expected to work cross-functionally while adhering to all of Eisai’s ethics and compliance standards.
Essential Functions 1. Achieve sales goals and drive appropriate utilization of assigned products through effective use of the Challenger Sales model, creating and maintaining an effective plan, and precise execution of sales and brand strategies; including effective and compliant utilization of available resources (i.e. approved sales aids and materials, educational lunches, speaker programs). 2. Collaborate with the Eisai team, including other field-based and home office personnel teams to proactively develop strategies that address customer needs, local market dynamics and trends, and support brand and corporate objectives within assigned geography. Includes participating in initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). 3. Develop deep knowledge of insomnia industry, local and regional market trends, disease state, product, and competitor knowledge. Leverage expertise and knowledge to anticipate and effectively manage business opportunities and challenges with HCPs in assigned geography (75-80% of targets will be General Practitioners and Family Medicine.) 4. Ensure individual compliance with Eisai policies and procedures.
Qualifications
Requirements •Bachelor’s degree required •2 or more years of pharmaceutical sales experience, strongly preferred •A minimum of 3 years of business-to-business sales experience, required •Strong business acumen •Demonstrated ability to establish and maintain strong business relationships. Proven ability to network and build strong relationships with customers •Valid US driver’s license and a driving record in compliance with company standards •Ability to safely and successfully operate a motor vehicle is required •Must successfully complete all company training programs and pass the company certification process, as well as all customer mandated and vendor credentialing requirements. •Strong verbal and written communication skills •Strong negotiating skills •Effective consultative selling skills •When necessary, travel overnight including within territory and to conferences, training and sales meetings.
Mar 31, 2020
The Medical Sales Professional (MSP) is responsible for growing, managing, developing, and representing Lemborexant in their respected territory. The MSP is the territory business owner responsible for creating strategies and executing tactics to generate product utilization that consistently achieve sales goals while conveying Eisai’s human health care mission (hhc). The Medical Sales Professional will be required to be an expert on all aspects of the insomnia, our product, and the competitive landscape, including coverage and reimbursement. They will build and develop professional relationships with appropriate HCPs and other healthcare professionals and office staff, and be expected to work cross-functionally while adhering to all of Eisai’s ethics and compliance standards.
Essential Functions 1. Achieve sales goals and drive appropriate utilization of assigned products through effective use of the Challenger Sales model, creating and maintaining an effective plan, and precise execution of sales and brand strategies; including effective and compliant utilization of available resources (i.e. approved sales aids and materials, educational lunches, speaker programs). 2. Collaborate with the Eisai team, including other field-based and home office personnel teams to proactively develop strategies that address customer needs, local market dynamics and trends, and support brand and corporate objectives within assigned geography. Includes participating in initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). 3. Develop deep knowledge of insomnia industry, local and regional market trends, disease state, product, and competitor knowledge. Leverage expertise and knowledge to anticipate and effectively manage business opportunities and challenges with HCPs in assigned geography (75-80% of targets will be General Practitioners and Family Medicine.) 4. Ensure individual compliance with Eisai policies and procedures.
Qualifications
Requirements •Bachelor’s degree required •2 or more years of pharmaceutical sales experience, strongly preferred •A minimum of 3 years of business-to-business sales experience, required •Strong business acumen •Demonstrated ability to establish and maintain strong business relationships. Proven ability to network and build strong relationships with customers •Valid US driver’s license and a driving record in compliance with company standards •Ability to safely and successfully operate a motor vehicle is required •Must successfully complete all company training programs and pass the company certification process, as well as all customer mandated and vendor credentialing requirements. •Strong verbal and written communication skills •Strong negotiating skills •Effective consultative selling skills •When necessary, travel overnight including within territory and to conferences, training and sales meetings.
The Neuroscience Area Manager provides product and disease state information in the Neurology market to a broad audience of health care professionals, while effectively communicating the clinical profile of Avanir’s products. In this role you will develop a personal strategy for communicating with healthcare professionals within the company guidelines. In this role you will provide daily activities including: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Essential Job Functions:
Provide current and comprehensive product and disease state information of the Neurology/Psychiatric market to a broad audience of health care professionals while effectively communicating the clinical profile of Avanir’s products.
Develop personal strategy for communicating with healthcare professionals within the company guidelines.
Daily activities include: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Execute sales force strategies and marketing plans effectively to meet or exceed sales objectives.
Review and analyze market data for developing and implementing business plans that focus on selling to targeted customer segments / business channels.
Partner with internal and external constituents to maximize customer satisfaction and drive profitable growth and sales targets.
Comply with all legal and regulatory compliance requirements established by Avanir.
Education/Qualifications:
A minimum of a Bachelor’s degree is required.
A valid driver’s license, with the ability to travel as needed (including overnights and/ or weekends) is required.
Two (2+) years of pharmaceutical/biopharmaceutical, medical, or related sales experience.
Experience working independently with direct responsibility for all business in an assigned territory/area/region.
Prior experience in the field of CNS/Psychiatry/Neurology, or within a specialty product sales force is preferred.
Previous product launch and/or first-in-class experience is preferred.
Proven and documented track record of sales success in an environment requiring high initiative, drive, accountability and maintaining a high level of compliant performance.
Ability to learn complex technical / scientific information and effectively communicate to a broad audience of health care professionals.
Takes ownership and demonstrates an entrepreneurial approach in territory management.
Demonstrates autonomy in decision making.
Demonstrates the ability to cultivate new and existing relationships within an assigned area.
Proactively identifies obstacles and responds by developing and implementing action plans to achieve challenging goals.
The ideal candidate should reside within assigned geography or within 25 miles of region boundaries.
Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, etc.)
Physical Requirements:
This position primarily works out of a vehicle, office environment or facility. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the offices or facilities. Travel by vehicle plane and other means is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate and lead meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
Work Environment:
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is exposed to moving vehicles, carts, and mechanical equipment (copiers, computers, coffee machines). May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate.
Mar 30, 2020
The Neuroscience Area Manager provides product and disease state information in the Neurology market to a broad audience of health care professionals, while effectively communicating the clinical profile of Avanir’s products. In this role you will develop a personal strategy for communicating with healthcare professionals within the company guidelines. In this role you will provide daily activities including: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Essential Job Functions:
Provide current and comprehensive product and disease state information of the Neurology/Psychiatric market to a broad audience of health care professionals while effectively communicating the clinical profile of Avanir’s products.
Develop personal strategy for communicating with healthcare professionals within the company guidelines.
Daily activities include: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Execute sales force strategies and marketing plans effectively to meet or exceed sales objectives.
Review and analyze market data for developing and implementing business plans that focus on selling to targeted customer segments / business channels.
Partner with internal and external constituents to maximize customer satisfaction and drive profitable growth and sales targets.
Comply with all legal and regulatory compliance requirements established by Avanir.
Education/Qualifications:
A minimum of a Bachelor’s degree is required.
A valid driver’s license, with the ability to travel as needed (including overnights and/ or weekends) is required.
Two (2+) years of pharmaceutical/biopharmaceutical, medical, or related sales experience.
Experience working independently with direct responsibility for all business in an assigned territory/area/region.
Prior experience in the field of CNS/Psychiatry/Neurology, or within a specialty product sales force is preferred.
Previous product launch and/or first-in-class experience is preferred.
Proven and documented track record of sales success in an environment requiring high initiative, drive, accountability and maintaining a high level of compliant performance.
Ability to learn complex technical / scientific information and effectively communicate to a broad audience of health care professionals.
Takes ownership and demonstrates an entrepreneurial approach in territory management.
Demonstrates autonomy in decision making.
Demonstrates the ability to cultivate new and existing relationships within an assigned area.
Proactively identifies obstacles and responds by developing and implementing action plans to achieve challenging goals.
The ideal candidate should reside within assigned geography or within 25 miles of region boundaries.
Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, etc.)
Physical Requirements:
This position primarily works out of a vehicle, office environment or facility. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the offices or facilities. Travel by vehicle plane and other means is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate and lead meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
Work Environment:
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is exposed to moving vehicles, carts, and mechanical equipment (copiers, computers, coffee machines). May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate.
The Neuroscience Area Manager provides product and disease state information in the Neurology market to a broad audience of health care professionals, while effectively communicating the clinical profile of Avanir’s products. In this role you will develop a personal strategy for communicating with healthcare professionals within the company guidelines. In this role you will provide daily activities including: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Essential Job Functions:
Provide current and comprehensive product and disease state information of the Neurology/Psychiatric market to a broad audience of health care professionals while effectively communicating the clinical profile of Avanir’s products.
Develop personal strategy for communicating with healthcare professionals within the company guidelines.
Daily activities include: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Execute sales force strategies and marketing plans effectively to meet or exceed sales objectives.
Review and analyze market data for developing and implementing business plans that focus on selling to targeted customer segments / business channels.
Partner with internal and external constituents to maximize customer satisfaction and drive profitable growth and sales targets.
Comply with all legal and regulatory compliance requirements established by Avanir.
Education/Qualifications:
A minimum of a Bachelor’s degree is required.
A valid driver’s license, with the ability to travel as needed (including overnights and/ or weekends) is required.
Two (2+) years of pharmaceutical/biopharmaceutical, medical, or related sales experience.
Experience working independently with direct responsibility for all business in an assigned territory/area/region.
Prior experience in the field of CNS/Psychiatry/Neurology, or within a specialty product sales force is preferred.
Previous product launch and/or first-in-class experience is preferred.
Proven and documented track record of sales success in an environment requiring high initiative, drive, accountability and maintaining a high level of compliant performance.
Ability to learn complex technical / scientific information and effectively communicate to a broad audience of health care professionals.
Takes ownership and demonstrates an entrepreneurial approach in territory management.
Demonstrates autonomy in decision making.
Demonstrates the ability to cultivate new and existing relationships within an assigned area.
Proactively identifies obstacles and responds by developing and implementing action plans to achieve challenging goals.
The ideal candidate should reside within assigned geography or within 25 miles of region boundaries.
Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, etc.)
Physical Requirements:
This position primarily works out of a vehicle, office environment or facility. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the offices or facilities. Travel by vehicle plane and other means is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate and lead meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
Work Environment:
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is exposed to moving vehicles, carts, and mechanical equipment (copiers, computers, coffee machines). May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate.
Mar 30, 2020
The Neuroscience Area Manager provides product and disease state information in the Neurology market to a broad audience of health care professionals, while effectively communicating the clinical profile of Avanir’s products. In this role you will develop a personal strategy for communicating with healthcare professionals within the company guidelines. In this role you will provide daily activities including: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Essential Job Functions:
Provide current and comprehensive product and disease state information of the Neurology/Psychiatric market to a broad audience of health care professionals while effectively communicating the clinical profile of Avanir’s products.
Develop personal strategy for communicating with healthcare professionals within the company guidelines.
Daily activities include: one-on-one sales presentations to targeted health care professionals including specialty physicians; arrangement of group selling programs; provide continuing education and value added services to a wide range of health care professionals; and analyze sales and market trends to effectively identify business opportunities.
Execute sales force strategies and marketing plans effectively to meet or exceed sales objectives.
Review and analyze market data for developing and implementing business plans that focus on selling to targeted customer segments / business channels.
Partner with internal and external constituents to maximize customer satisfaction and drive profitable growth and sales targets.
Comply with all legal and regulatory compliance requirements established by Avanir.
Education/Qualifications:
A minimum of a Bachelor’s degree is required.
A valid driver’s license, with the ability to travel as needed (including overnights and/ or weekends) is required.
Two (2+) years of pharmaceutical/biopharmaceutical, medical, or related sales experience.
Experience working independently with direct responsibility for all business in an assigned territory/area/region.
Prior experience in the field of CNS/Psychiatry/Neurology, or within a specialty product sales force is preferred.
Previous product launch and/or first-in-class experience is preferred.
Proven and documented track record of sales success in an environment requiring high initiative, drive, accountability and maintaining a high level of compliant performance.
Ability to learn complex technical / scientific information and effectively communicate to a broad audience of health care professionals.
Takes ownership and demonstrates an entrepreneurial approach in territory management.
Demonstrates autonomy in decision making.
Demonstrates the ability to cultivate new and existing relationships within an assigned area.
Proactively identifies obstacles and responds by developing and implementing action plans to achieve challenging goals.
The ideal candidate should reside within assigned geography or within 25 miles of region boundaries.
Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, etc.)
Physical Requirements:
This position primarily works out of a vehicle, office environment or facility. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the offices or facilities. Travel by vehicle plane and other means is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate and lead meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
Work Environment:
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is exposed to moving vehicles, carts, and mechanical equipment (copiers, computers, coffee machines). May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate.
The Specialty Sales Consultant is responsible for establishing and building business relationships with key influencers and achieving targeted sales goals within the assigned territory while adhering to all ALUSA-defined ethical sales practices, PhRMA guidelines, and required promotional regulations. Develop and maintain an in-depth knowledge of products and disease states and engage in meaningful dialogue with healthcare providers to ensure the appropriate use of our portfolio of brands.
KEY RESPONSIBILITIES :
Understand and execute on ALUSA strategy and plans at the prescriber level.
Utilize effective selling skills and product knowledge to influence targeted health care providers to prescribe ALUSA promoted products with appropriate patients. Execute brand strategies to ensure a consistent sales and marketing message.
Develop and execute account and territory plans/strategy ascribing to the principles of key physician/account prioritization, daily call reporting and sample management.
Prioritizes time, effort and resources to ensure optimal coverage of appropriate targets based on opportunity and potential.
Support targeted customers using ALUSA approved resources, sales materials, and promotional activities/programs.
Leverages market and customer data to better inform strategic business planning.
Develop and maintain relationships with HCP’s in the territory and establish relationships with pertinent medical institutions.
Represent ALUSA to selected Key Opinion Leaders (KOLs) in order to educate on benefits of our products through the use of clinical studies and other support material.
Meet call plan expectations and achieve territory sales goals in a compliant manner.
Actively participate in scheduled Company sales meetings, district and regional conference calls and other business meetings as required.
Meet all administrative requirements including budget management, sample management, expense reporting and completes all required training as directed by sales management.
Requirements
Bachelor's degree required; life sciences and/or business degree preferred
2-4 years of pharmaceutical sales experience, B2B, medical device and/or hospital sales experience. GI experience highly desirable
Proven track record of consistent high performance
Demonstrated experience launching products
Strong business and financial acumen and ability to understand market opportunities
Strong leadership and organizational skills
Excellent relationship building and listening skills with a focus on solutions-based selling
Excellent oral and written communication and facilitation skills
Strong influencing and selling skills; seamless sales execution from pre-call planning through closing
Energetic, adaptable, team player, self-motivated, thrives on challenge
Demonstrates high ethical and professional standards and operates with a sense of urgency
Proficient in MS Office Suite, Office 365 preferred
Experience with CRM software and navigating an iPad
Must be available to travel up 25-30% or as required by the specific territory
Must reside within the territory or within reasonable driving distance (25 miles or less) to ensure the effective management and coverage of the territory
A valid driver’s license in good standing
Mar 30, 2020
The Specialty Sales Consultant is responsible for establishing and building business relationships with key influencers and achieving targeted sales goals within the assigned territory while adhering to all ALUSA-defined ethical sales practices, PhRMA guidelines, and required promotional regulations. Develop and maintain an in-depth knowledge of products and disease states and engage in meaningful dialogue with healthcare providers to ensure the appropriate use of our portfolio of brands.
KEY RESPONSIBILITIES :
Understand and execute on ALUSA strategy and plans at the prescriber level.
Utilize effective selling skills and product knowledge to influence targeted health care providers to prescribe ALUSA promoted products with appropriate patients. Execute brand strategies to ensure a consistent sales and marketing message.
Develop and execute account and territory plans/strategy ascribing to the principles of key physician/account prioritization, daily call reporting and sample management.
Prioritizes time, effort and resources to ensure optimal coverage of appropriate targets based on opportunity and potential.
Support targeted customers using ALUSA approved resources, sales materials, and promotional activities/programs.
Leverages market and customer data to better inform strategic business planning.
Develop and maintain relationships with HCP’s in the territory and establish relationships with pertinent medical institutions.
Represent ALUSA to selected Key Opinion Leaders (KOLs) in order to educate on benefits of our products through the use of clinical studies and other support material.
Meet call plan expectations and achieve territory sales goals in a compliant manner.
Actively participate in scheduled Company sales meetings, district and regional conference calls and other business meetings as required.
Meet all administrative requirements including budget management, sample management, expense reporting and completes all required training as directed by sales management.
Requirements
Bachelor's degree required; life sciences and/or business degree preferred
2-4 years of pharmaceutical sales experience, B2B, medical device and/or hospital sales experience. GI experience highly desirable
Proven track record of consistent high performance
Demonstrated experience launching products
Strong business and financial acumen and ability to understand market opportunities
Strong leadership and organizational skills
Excellent relationship building and listening skills with a focus on solutions-based selling
Excellent oral and written communication and facilitation skills
Strong influencing and selling skills; seamless sales execution from pre-call planning through closing
Energetic, adaptable, team player, self-motivated, thrives on challenge
Demonstrates high ethical and professional standards and operates with a sense of urgency
Proficient in MS Office Suite, Office 365 preferred
Experience with CRM software and navigating an iPad
Must be available to travel up 25-30% or as required by the specific territory
Must reside within the territory or within reasonable driving distance (25 miles or less) to ensure the effective management and coverage of the territory
A valid driver’s license in good standing
The Professional Sales Representative (PSR) is engaging Health Care Professionals (HCPs) in face to face discussions to promote assigned client product(s), maximize the product(s) selling potential and meet program and Client objectives. The PSR achieves this by developing and maintaining relationships with HCPs and educating them about product features, benefits, safety profile and approved indications to ensure appropriate patient use. The PSR utilizes approved tools and resources for product promotion and maintains a competent level of product, territory and customer activity knowledge.
QUALIFICATIONS:
Minimal Requirements
Cardiovascular Experience Preferred
o Bachelors degree (any major) from an accredited college or university is required.
o Prior pharmaceutical sales within the identified territory considered but not required
o Entry level or new to industry candidates considered
o Knowledge of the medical, healthcare or pharmacy industry and skills in clinical selling are preferred
o Demonstrated effective organizational and communication skills
o Leadership, self-motivation and initiative
o Demonstrated judgment and decision-making capability
o Be results oriented with demonstrated time management skills
o Ability to learn, analyze, understand and convey complex information
o Demonstrated technical aptitude and computer skills are essential
o A valid driver's license and safe driving record
KNOWLEDGE SKILLS & ABILITIES:
o Excellent verbal, written and interpersonal communication skills.
o Clear, articulate and grammatically sound speech.
o Strong focus on providing customers with superior support and service.
o Ability to learn, understand and communicate complex information.
o Strong rapport building skills and active listening skills.
o Excellent selling, closing, persuasion and presentation skills.
o Ability to display high-levels of initiative, effort and commitment successfully complete projects and assignments.
o Ability to comprehend and communicate complex technical/medical terminology and to maintain the required technical expertise including competitive product knowledge.
o Must be self-motivated and disciplined.
o Good organizational and planning skills, strong attention to detail and accuracy.
o Ability to work independently and as a team member.
o Flexibility and ability to handle multiple tasks simultaneously.
o Must be able to deal with people at all levels inside and outside of the company.
Mar 30, 2020
The Professional Sales Representative (PSR) is engaging Health Care Professionals (HCPs) in face to face discussions to promote assigned client product(s), maximize the product(s) selling potential and meet program and Client objectives. The PSR achieves this by developing and maintaining relationships with HCPs and educating them about product features, benefits, safety profile and approved indications to ensure appropriate patient use. The PSR utilizes approved tools and resources for product promotion and maintains a competent level of product, territory and customer activity knowledge.
QUALIFICATIONS:
Minimal Requirements
Cardiovascular Experience Preferred
o Bachelors degree (any major) from an accredited college or university is required.
o Prior pharmaceutical sales within the identified territory considered but not required
o Entry level or new to industry candidates considered
o Knowledge of the medical, healthcare or pharmacy industry and skills in clinical selling are preferred
o Demonstrated effective organizational and communication skills
o Leadership, self-motivation and initiative
o Demonstrated judgment and decision-making capability
o Be results oriented with demonstrated time management skills
o Ability to learn, analyze, understand and convey complex information
o Demonstrated technical aptitude and computer skills are essential
o A valid driver's license and safe driving record
KNOWLEDGE SKILLS & ABILITIES:
o Excellent verbal, written and interpersonal communication skills.
o Clear, articulate and grammatically sound speech.
o Strong focus on providing customers with superior support and service.
o Ability to learn, understand and communicate complex information.
o Strong rapport building skills and active listening skills.
o Excellent selling, closing, persuasion and presentation skills.
o Ability to display high-levels of initiative, effort and commitment successfully complete projects and assignments.
o Ability to comprehend and communicate complex technical/medical terminology and to maintain the required technical expertise including competitive product knowledge.
o Must be self-motivated and disciplined.
o Good organizational and planning skills, strong attention to detail and accuracy.
o Ability to work independently and as a team member.
o Flexibility and ability to handle multiple tasks simultaneously.
o Must be able to deal with people at all levels inside and outside of the company.
We are seeking high performing, Medical Science Liaison First Line Field Managers to join our new MSL team. Strong leaders possessing previous MSL Team Management, Medical Affairs, Clinical Educator, are encouraged to apply.
Be part of new MSL team utilizing your MSL/Medical Affairs first line management experience in anticipation of a new drug launch in 2020. Our client is focused on non-absorbed therapies for patients with chronic kidney disease in new and novel ways.
In your role you will have significant impact during this important stage of our client’s growth managing a new team of Nephrology MSL’s. As part of this inaugural MSL team, you will provide direction and leadership, including some hiring, of new MSL’s. As an Amplity employee, you will work closely with our client and multiple stakeholders within our organization.
Our Regional Directors will enjoy a generous base salary, bonus potential, auto allowance, attractive benefits package including 401K, medical, dental, vision, LTD, STD, Vacation, and Paid Holidays.
If you want to be a part of building and growing a new team, while impacting patients suffering with CKD partnering with a top biotech organization, please respond immediately. We are moving rapidly, building our new team.
The Regional Director is responsible for performance standards of assigned MSLs. In their region The RD is responsible for managing various aspects of the Medical Affairs employment experience (recruiting and hiring, performance management and corrective action, administrative, reconciliation and expense management, employee relations related issues). The MSL RD works closely with Client management to support all project goals, removes barriers to successful achievement of desired results and recognizes and responds to client’s needs.
Essential Duties/ Responsibilities:
Translate program requirements into operational tasks for successful execution of contractual deliverables, and delivery of results manage MSLs in all areas of their employment. Plan, organize and monitor team member assignments, collaborative efforts with Client contacts, activities and projects to achieve client objectives
Effectively plan and facilitate required meetings
Monitor team members’ territory performance and productivity/metrics, workload and outputs while ensuring compliance with policies and processes and addressing issues through corrective action process as they arise
Interview and select qualified candidates for vacancies on the team utilizing Amplity recruiting guidelines
Monitor employee compliance with all company policies and procedures and engage/work with Amplity Compliance to resolve issues and follow up with disciplinary action when needed
Be budget conscious respecting spending limit guidelines where appropriate
Provide all co-employment administrative oversight –manage team members' attendance, approve time off, schedules, expense reports, etc.
Fully comply with, and ensure that all direct reports fully comply with all local, state and federal laws, regulations and Amplity and Client Policies, Code of Conduct, PhRMA Guidelines, and all privacy and data guidelines
Assist team with utilization of all technology requirements, if applicable: CRM use, expense and OSIM reporting, activity reports, and other reports as needed
Perform special projects and assignments as directed by the manager
Key Working Relationships:
Reports to Amplity Management
Frequent collaboration with Amplity on aspects pertaining to supervision of MSLs
Frequent collaboration with Client teams on MSL activity and progress
Collaborates with Amplity Project Manager and other Amplity home office support
Maintains a positive working relationship with all Client and Amplity contacts
Requirements:
Minimum Bachelor’s degree Required, RN/MSN/PA or Terminal Degree strongly preferred
2+ years of prior experience in a pharma role (e.g. MSL, CSL, etc.)
3-5 years of pharmaceutical experience managing a field based clinically focused team
Ability to travel within the assigned region (car and air travel). As needed-up to 70% travel including related meetings and functions (including overnights, weekends and/or international as opportunities demand).
Live near a major airport
A valid driver's license and safe driving record
Possess a valid passport
Working proficiency in Microsoft Word, Excel, and Outlook.
Preferred:
MSL Management experience
CSO Management experience
Project Management experience
Nephrology
Start-up
Pre-PDUFA Product Launch
Knowledge, Skills and Abilities:
Excellent people management/supervisory skills; strong ability to develop medical professionals, and ability to lead and mentor the team
Demonstrated coaching skills
Ability to recruit, retain and develop high performing talent; ability to manage turnover and vacancy process
Strong process facilitation, problem solving and analytical thinking abilities to make sound business decisions
Strong rapport building and active listening skills
Good organizational, planning skills, strong attention to detail and accuracy in recording/handling client and project information
Excellent verbal, written and interpersonal communication skills.
Highly flexible and able to successfully operate in a fast-paced environment.
Must be able to deal with people at all levels inside and outside of the company.
Mar 30, 2020
We are seeking high performing, Medical Science Liaison First Line Field Managers to join our new MSL team. Strong leaders possessing previous MSL Team Management, Medical Affairs, Clinical Educator, are encouraged to apply.
Be part of new MSL team utilizing your MSL/Medical Affairs first line management experience in anticipation of a new drug launch in 2020. Our client is focused on non-absorbed therapies for patients with chronic kidney disease in new and novel ways.
In your role you will have significant impact during this important stage of our client’s growth managing a new team of Nephrology MSL’s. As part of this inaugural MSL team, you will provide direction and leadership, including some hiring, of new MSL’s. As an Amplity employee, you will work closely with our client and multiple stakeholders within our organization.
Our Regional Directors will enjoy a generous base salary, bonus potential, auto allowance, attractive benefits package including 401K, medical, dental, vision, LTD, STD, Vacation, and Paid Holidays.
If you want to be a part of building and growing a new team, while impacting patients suffering with CKD partnering with a top biotech organization, please respond immediately. We are moving rapidly, building our new team.
The Regional Director is responsible for performance standards of assigned MSLs. In their region The RD is responsible for managing various aspects of the Medical Affairs employment experience (recruiting and hiring, performance management and corrective action, administrative, reconciliation and expense management, employee relations related issues). The MSL RD works closely with Client management to support all project goals, removes barriers to successful achievement of desired results and recognizes and responds to client’s needs.
Essential Duties/ Responsibilities:
Translate program requirements into operational tasks for successful execution of contractual deliverables, and delivery of results manage MSLs in all areas of their employment. Plan, organize and monitor team member assignments, collaborative efforts with Client contacts, activities and projects to achieve client objectives
Effectively plan and facilitate required meetings
Monitor team members’ territory performance and productivity/metrics, workload and outputs while ensuring compliance with policies and processes and addressing issues through corrective action process as they arise
Interview and select qualified candidates for vacancies on the team utilizing Amplity recruiting guidelines
Monitor employee compliance with all company policies and procedures and engage/work with Amplity Compliance to resolve issues and follow up with disciplinary action when needed
Be budget conscious respecting spending limit guidelines where appropriate
Provide all co-employment administrative oversight –manage team members' attendance, approve time off, schedules, expense reports, etc.
Fully comply with, and ensure that all direct reports fully comply with all local, state and federal laws, regulations and Amplity and Client Policies, Code of Conduct, PhRMA Guidelines, and all privacy and data guidelines
Assist team with utilization of all technology requirements, if applicable: CRM use, expense and OSIM reporting, activity reports, and other reports as needed
Perform special projects and assignments as directed by the manager
Key Working Relationships:
Reports to Amplity Management
Frequent collaboration with Amplity on aspects pertaining to supervision of MSLs
Frequent collaboration with Client teams on MSL activity and progress
Collaborates with Amplity Project Manager and other Amplity home office support
Maintains a positive working relationship with all Client and Amplity contacts
Requirements:
Minimum Bachelor’s degree Required, RN/MSN/PA or Terminal Degree strongly preferred
2+ years of prior experience in a pharma role (e.g. MSL, CSL, etc.)
3-5 years of pharmaceutical experience managing a field based clinically focused team
Ability to travel within the assigned region (car and air travel). As needed-up to 70% travel including related meetings and functions (including overnights, weekends and/or international as opportunities demand).
Live near a major airport
A valid driver's license and safe driving record
Possess a valid passport
Working proficiency in Microsoft Word, Excel, and Outlook.
Preferred:
MSL Management experience
CSO Management experience
Project Management experience
Nephrology
Start-up
Pre-PDUFA Product Launch
Knowledge, Skills and Abilities:
Excellent people management/supervisory skills; strong ability to develop medical professionals, and ability to lead and mentor the team
Demonstrated coaching skills
Ability to recruit, retain and develop high performing talent; ability to manage turnover and vacancy process
Strong process facilitation, problem solving and analytical thinking abilities to make sound business decisions
Strong rapport building and active listening skills
Good organizational, planning skills, strong attention to detail and accuracy in recording/handling client and project information
Excellent verbal, written and interpersonal communication skills.
Highly flexible and able to successfully operate in a fast-paced environment.
Must be able to deal with people at all levels inside and outside of the company.
The Key Account Manager role is responsible for developing key relationships with targeted regional and local hospital systems including select Integrated Delivery Networks (IDNs), Accountable Care Organizations (ACOs), Group Purchasing Organizations (GPOs), and Infectious Disease Infusion Centers. This position will develop and own account management plans for targeted accounts - to attain key sales objectives for Paratek’s products. The position will also be responsible for implementing short-and long-term business initiatives to ensure product access within a specified geography. The KAM is responsible for product positioning, formulary contracting and institutional purchasing access for Paratek’s lead commercial product, to obtain patient and provider access within targeted accounts.
The KAM ensures that the needs of, and opportunities in, assigned accounts are communicated to Market Access leadership and other internal stakeholders so that they can be integrated into strategic planning and forecasting as appropriate.
This role is embedded into the Paratek Pharmaceuticals’ (Paratek) Market Access team, receiving day to day direction from the Director, IDN/GPO Account Management. The role will initially be an employee of Amplity Health.
Position Responsibilities:
Develop and grow business partnerships within the accounts in the defined geography.
Leverage a deep understanding of each customer’s business processes and environment and actively engage with the intention of gaining unrestricted formulary access to achieve performance goals.
Assess product positioning and develop strategic plans for regional and local customers who may include IDNs, ACOs, ID Infusion Centers and other account targets.
Develop short and long-term business plans for regional and local accounts that address brand initiatives and regional sales goals.
Focus on a vertical integration plan within all assigned accounts, which includes Medical/Pharmacy and Purchasing Directors (clinical and administrative), case managers, and other medical management team members.
Utilize Active Account Planning to execute an integrated Business Plan for each assigned Account. Development of the Account Business plans requires an intimate knowledge of the customer and market influences affecting their business.
Monitor progress in accounts and modify and update action plans as appropriate (monitor customer contacts, plan execution, value, volume growth, and market share).
Develop a strong alliance with field-based colleagues to ensure the appropriate level of cross-functional support for customers within a defined geography and for developing and executing pull-through strategies as directed by the Regional Business Director.
Report progress in assigned accounts through business plan updates to Market Access and Sales leadership, as required. Monitor, track and improve key performance indicators as identified by scorecard metrics.
Effectively implement and manage all programs as directed by Market Access leadership.
Be a resource to sales partners on important payer trends, reimbursement changes, and billing requirements that may affect product utilization.
Identify and allocate appropriate resources; track results over time and adjust priorities and resources as customers and markets change during the performance period.
Candidate Requirements:
Bachelor's degree required.
A minimum of 5+ years successful experience calling on IDNs and ACOs in addition to securing product access with the hospital and institutional markets.
Demonstrated knowledge of payer decision-making for policy, coverage, coding and patient access to existing and new products.
Demonstrated knowledge of the inpatient out outpatient reimbursement process.
Infectious disease therapeutic knowledge, preferred
Exceptional communication skills that include verbal, written and presentation abilities.
Effective negotiation skills with examples of results. Demonstrated problem-solving capabilities through strategic planning, leadership and organizational skills.
Ability to skillfully negotiate in tough situations with both internal and external customers while working within an ever-changing payer, managed markets and corporate environment.
Valid driver’s license.
Additional Information:
Technology: Microsoft Office Suite, Veeva (preferred).
Travel (%): The average travel for this position is 40-50% with some variation based upon the time of year and demands of the business imperatives. The travel requirements will vary based on the geography and account responsibilities for this position.
Mar 30, 2020
The Key Account Manager role is responsible for developing key relationships with targeted regional and local hospital systems including select Integrated Delivery Networks (IDNs), Accountable Care Organizations (ACOs), Group Purchasing Organizations (GPOs), and Infectious Disease Infusion Centers. This position will develop and own account management plans for targeted accounts - to attain key sales objectives for Paratek’s products. The position will also be responsible for implementing short-and long-term business initiatives to ensure product access within a specified geography. The KAM is responsible for product positioning, formulary contracting and institutional purchasing access for Paratek’s lead commercial product, to obtain patient and provider access within targeted accounts.
The KAM ensures that the needs of, and opportunities in, assigned accounts are communicated to Market Access leadership and other internal stakeholders so that they can be integrated into strategic planning and forecasting as appropriate.
This role is embedded into the Paratek Pharmaceuticals’ (Paratek) Market Access team, receiving day to day direction from the Director, IDN/GPO Account Management. The role will initially be an employee of Amplity Health.
Position Responsibilities:
Develop and grow business partnerships within the accounts in the defined geography.
Leverage a deep understanding of each customer’s business processes and environment and actively engage with the intention of gaining unrestricted formulary access to achieve performance goals.
Assess product positioning and develop strategic plans for regional and local customers who may include IDNs, ACOs, ID Infusion Centers and other account targets.
Develop short and long-term business plans for regional and local accounts that address brand initiatives and regional sales goals.
Focus on a vertical integration plan within all assigned accounts, which includes Medical/Pharmacy and Purchasing Directors (clinical and administrative), case managers, and other medical management team members.
Utilize Active Account Planning to execute an integrated Business Plan for each assigned Account. Development of the Account Business plans requires an intimate knowledge of the customer and market influences affecting their business.
Monitor progress in accounts and modify and update action plans as appropriate (monitor customer contacts, plan execution, value, volume growth, and market share).
Develop a strong alliance with field-based colleagues to ensure the appropriate level of cross-functional support for customers within a defined geography and for developing and executing pull-through strategies as directed by the Regional Business Director.
Report progress in assigned accounts through business plan updates to Market Access and Sales leadership, as required. Monitor, track and improve key performance indicators as identified by scorecard metrics.
Effectively implement and manage all programs as directed by Market Access leadership.
Be a resource to sales partners on important payer trends, reimbursement changes, and billing requirements that may affect product utilization.
Identify and allocate appropriate resources; track results over time and adjust priorities and resources as customers and markets change during the performance period.
Candidate Requirements:
Bachelor's degree required.
A minimum of 5+ years successful experience calling on IDNs and ACOs in addition to securing product access with the hospital and institutional markets.
Demonstrated knowledge of payer decision-making for policy, coverage, coding and patient access to existing and new products.
Demonstrated knowledge of the inpatient out outpatient reimbursement process.
Infectious disease therapeutic knowledge, preferred
Exceptional communication skills that include verbal, written and presentation abilities.
Effective negotiation skills with examples of results. Demonstrated problem-solving capabilities through strategic planning, leadership and organizational skills.
Ability to skillfully negotiate in tough situations with both internal and external customers while working within an ever-changing payer, managed markets and corporate environment.
Valid driver’s license.
Additional Information:
Technology: Microsoft Office Suite, Veeva (preferred).
Travel (%): The average travel for this position is 40-50% with some variation based upon the time of year and demands of the business imperatives. The travel requirements will vary based on the geography and account responsibilities for this position.
In partnership with one of our top tier pharmaceutical clients we are building a new CDx-Companion Diagnostic team in a non-sales role. This opportunity allows strong performers to capitalize on successful oncology and diagnostic background in a different way. We are seeking team-oriented, driven, clinically and technically focused oncology diagnostic representatives possessing experience and existing relationships in pathology, oncology, labs in this dynamic market space. This is a new team build.
In partnership with our client, Amplity will be offering a lucrative base salary, with bonus and competitive benefit package, including 401K. We understand the importance of recruiting and retaining the best talent and are prepared to compensate you for your oncology and diagnostics experience, customer relationships and success. This is not a sales position, but those with previous oncology diagnostic experience are strongly preferred.
CDx Oncology Education Specialist will provide disease and Oncology CDx Education calling on Pathologists, Oncologists, labs and the top 100 Oncology Centers of Excellence within the region. Residence near a major airport is required along with the willingness to travel extensively within multiple states on a weekly basis.
Please apply at once if you are ready to use your strong oncology diagnostic sales experience in a unique educational and supportive role. Requirements:
Bachelor’s degree required;
On average of 4 to 5 years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales;
Strong technical background in molecular biology, genomics, Immunohistochemistry or immunology, a plus;
Relationships with Pathologists and/or Oncologist strongly preferred;
60% - 70% travel;
A valid driver's license and clean driving record;
Account and Territory Management experience.
Knowledge, Skills and Abilities:
Clinical and Business Acumen in the oncology and diagnostic arena;
Excellent verbal, written and interpersonal communication skills;
Excellent collaboration skills and ability to work independently and as a team member with multiple parties.
Mar 30, 2020
In partnership with one of our top tier pharmaceutical clients we are building a new CDx-Companion Diagnostic team in a non-sales role. This opportunity allows strong performers to capitalize on successful oncology and diagnostic background in a different way. We are seeking team-oriented, driven, clinically and technically focused oncology diagnostic representatives possessing experience and existing relationships in pathology, oncology, labs in this dynamic market space. This is a new team build.
In partnership with our client, Amplity will be offering a lucrative base salary, with bonus and competitive benefit package, including 401K. We understand the importance of recruiting and retaining the best talent and are prepared to compensate you for your oncology and diagnostics experience, customer relationships and success. This is not a sales position, but those with previous oncology diagnostic experience are strongly preferred.
CDx Oncology Education Specialist will provide disease and Oncology CDx Education calling on Pathologists, Oncologists, labs and the top 100 Oncology Centers of Excellence within the region. Residence near a major airport is required along with the willingness to travel extensively within multiple states on a weekly basis.
Please apply at once if you are ready to use your strong oncology diagnostic sales experience in a unique educational and supportive role. Requirements:
Bachelor’s degree required;
On average of 4 to 5 years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales;
Strong technical background in molecular biology, genomics, Immunohistochemistry or immunology, a plus;
Relationships with Pathologists and/or Oncologist strongly preferred;
60% - 70% travel;
A valid driver's license and clean driving record;
Account and Territory Management experience.
Knowledge, Skills and Abilities:
Clinical and Business Acumen in the oncology and diagnostic arena;
Excellent verbal, written and interpersonal communication skills;
Excellent collaboration skills and ability to work independently and as a team member with multiple parties.
Job Description
• In the absence of the center manager, overall authority over center operations production goals, monitor net yields and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain operational records. • Independently determine center labor usage to meet business needs. Support meeting the established center production goals. • In collaboration with center manager, manage all inventories to the optimum levels by maximizing efficiencies, customer service levels and minimizing investment. Support meeting daily, weekly and monthly deadlines and maintain center’s operational records. • Ensure efficient donor flow throughout the center. Identify problem areas and implement corrective action as needed. • In collaboration with center manager, ensure compliance with all Company SOPs and applicable federal, state and local regulations. Perform nearly all staff tasks and duties at a proficiency level adequate for training and critiquing employees in the performance of those tasks and duties. • In absence of center manager, responsible for all aspects of financial oversight. Responsible for center production goals. Monitors net yields and implements plans for improvement when required. Consistently meets daily, weekly and monthly deadlines and maintains center’s operational records. • In collaboration with center manager, ensure meets financial targets at all times and adheres to cash management, financial reporting, and other financial responsibilities. • In collaboration with center manager, support the center philosophy of continuous improvement. Collect and analyze data to maintain and improve center quality, efficiency and profitability. Implement effective corrective action plans when appropriate. • In collaboration with center and quality management, assist quality compliance by meeting company, regulatory and customer requirements to safeguard the purity and efficacy of the plasma and the safety of donors and employees. • In collaboration with center and quality management, assist with all audits by working with quality personnel and QA team to develop effective corrective action plans to address any areas of deficiency noted during audits. • Follow all HSE and OSHA policies and procedures. In collaboration with center manager, ensure the center and all employees comply with OSHA regulations and training. Complete all OSHA record keeping and reporting requirements. • In collaboration with center manager, maintain clean efficient work environment, and ensure center has sufficient operating supplies and forms. May conduct routine internal procedures and documentation audits. • Support facility maintenance to highest safety, compliance and cleanliness standards. Partner with corporate facilities to ensure center compliance at all times. • In collaboration with center manager, conduct recruitment, training, development, counseling and termination. Manage effectively employee turnover within center operations. Adhere to HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure compliance. • In collaboration with center manager, ensure excellent customer service by all staff. Provide a model of good customer service to employees. Communicate openly with customers. Effectively resolve complaints or concerns. • In collaboration with center manager, support all marketing and advertising to ensure effectively executing programs for desired results. Make applicable recommendations to improve effectiveness. • In collaboration with center manager, represent the Company and center in the community and with other business, local publications and vendors. • Maintain confidentiality of all personnel, donor and center information. • Perform other job-related duties as assigned.
Education • Bachelor’s Degree preferred • Equivalent combination of education and professional work experience required
Experience • Minimum 1 year supervisory or leadership experience responsible for overseeing the activities of others required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department’s creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Reach, bend, kneel and have high level of manual dexterity to lift boxes, carry instruments, pull or push furniture and/or supplies • Overnight travel required up to 10% of the time • Generally spends 80% of the time standing and walking and 20% of the time sitting • Occasionally lift and carry up to 25 lbs. • Occasionally perform tasks while standing and walking up to 100% of the time • See, hear and speak with customers and center employees • Approximately 60% of the time is spent managing center by auditing, improving operations and observing ongoing operations through the center • Exposure to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Fast paced environment with frequent interruptions
Mar 30, 2020
Job Description
• In the absence of the center manager, overall authority over center operations production goals, monitor net yields and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain operational records. • Independently determine center labor usage to meet business needs. Support meeting the established center production goals. • In collaboration with center manager, manage all inventories to the optimum levels by maximizing efficiencies, customer service levels and minimizing investment. Support meeting daily, weekly and monthly deadlines and maintain center’s operational records. • Ensure efficient donor flow throughout the center. Identify problem areas and implement corrective action as needed. • In collaboration with center manager, ensure compliance with all Company SOPs and applicable federal, state and local regulations. Perform nearly all staff tasks and duties at a proficiency level adequate for training and critiquing employees in the performance of those tasks and duties. • In absence of center manager, responsible for all aspects of financial oversight. Responsible for center production goals. Monitors net yields and implements plans for improvement when required. Consistently meets daily, weekly and monthly deadlines and maintains center’s operational records. • In collaboration with center manager, ensure meets financial targets at all times and adheres to cash management, financial reporting, and other financial responsibilities. • In collaboration with center manager, support the center philosophy of continuous improvement. Collect and analyze data to maintain and improve center quality, efficiency and profitability. Implement effective corrective action plans when appropriate. • In collaboration with center and quality management, assist quality compliance by meeting company, regulatory and customer requirements to safeguard the purity and efficacy of the plasma and the safety of donors and employees. • In collaboration with center and quality management, assist with all audits by working with quality personnel and QA team to develop effective corrective action plans to address any areas of deficiency noted during audits. • Follow all HSE and OSHA policies and procedures. In collaboration with center manager, ensure the center and all employees comply with OSHA regulations and training. Complete all OSHA record keeping and reporting requirements. • In collaboration with center manager, maintain clean efficient work environment, and ensure center has sufficient operating supplies and forms. May conduct routine internal procedures and documentation audits. • Support facility maintenance to highest safety, compliance and cleanliness standards. Partner with corporate facilities to ensure center compliance at all times. • In collaboration with center manager, conduct recruitment, training, development, counseling and termination. Manage effectively employee turnover within center operations. Adhere to HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure compliance. • In collaboration with center manager, ensure excellent customer service by all staff. Provide a model of good customer service to employees. Communicate openly with customers. Effectively resolve complaints or concerns. • In collaboration with center manager, support all marketing and advertising to ensure effectively executing programs for desired results. Make applicable recommendations to improve effectiveness. • In collaboration with center manager, represent the Company and center in the community and with other business, local publications and vendors. • Maintain confidentiality of all personnel, donor and center information. • Perform other job-related duties as assigned.
Education • Bachelor’s Degree preferred • Equivalent combination of education and professional work experience required
Experience • Minimum 1 year supervisory or leadership experience responsible for overseeing the activities of others required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department’s creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Reach, bend, kneel and have high level of manual dexterity to lift boxes, carry instruments, pull or push furniture and/or supplies • Overnight travel required up to 10% of the time • Generally spends 80% of the time standing and walking and 20% of the time sitting • Occasionally lift and carry up to 25 lbs. • Occasionally perform tasks while standing and walking up to 100% of the time • See, hear and speak with customers and center employees • Approximately 60% of the time is spent managing center by auditing, improving operations and observing ongoing operations through the center • Exposure to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Fast paced environment with frequent interruptions
Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA).
Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations and monitors medical compliance of the center. Either serves as or delegates to another appropriate physician the duties of “laboratory director”, “technical consultant”, or “clinical consultant” as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA). Assures that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
Reviews, understands, and complies with all CSL Plasma Services policies and procedures in the performance of services. Maintains high medical standards and ensures that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities. Is physically present at the center for agreed upon hours.
Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate. Trains other physicians. Evaluates newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs. Functionally directs the Center Medical Staff. Provides training to other center staff on medically related procedures and practices.
Reviews and signed Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communication.
Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center. Serves as a member of the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, which includes preparation of monthly reports and periodic conference calls.
Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis. Responds to calls from and provides instruction to Center Medical Staff with donor suitability questions. Conducts confidential and effective interviews with donors to obtain information in a variety of situations. Interviews donors with positive STS/negative FTA and documents approval to resume donating.
Maintains confidentiality with respect to employee, donor and center records reviewed during the course of all duties. Responsible for overseeing maintenance of medical supplies ad other emergency equipment.
Reviews and sings moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews abnormal test results including abnormal serum protein electrophoresis (SPE) test results and donor record lc-PD-09195 Page 2 files. Reviews normal SPE test results following an abnormal one and documents approval to resume donating.
Assures the health and safety of donors participating in the non-red blood cell immunization programs, if applicable. Monitors donor clinical response to immunizations, when applicable. Oversees hyper-immune programs, if applicable. For red cell recipients in the Anti-D Program, if applicable: Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment; provides review and approval for red blood cell immunization; is present when red cell immunizations are given. Submits monthly report to Divisional (or Corporate) Medical Director.
Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director. Maintains current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.)
May perform Center Physician functions including but not limited to notifying donors of unsuitable test results, performing screening medical evaluations, assessing results of donor screening and laboratory tests to determine a donor’s initial and continued suitability for plasmapheresis, explaining informed consent materials to donors.
Performs additional services as and when requested by the company.
Education
MD or DO degree from an accredited medical or osteopathic school. Must maintain a current and active medical license in the state in which the Center is located.
Experience
One year of residency training as an MD or OD.
Mar 30, 2020
Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA).
Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations and monitors medical compliance of the center. Either serves as or delegates to another appropriate physician the duties of “laboratory director”, “technical consultant”, or “clinical consultant” as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA). Assures that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
Reviews, understands, and complies with all CSL Plasma Services policies and procedures in the performance of services. Maintains high medical standards and ensures that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities. Is physically present at the center for agreed upon hours.
Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate. Trains other physicians. Evaluates newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs. Functionally directs the Center Medical Staff. Provides training to other center staff on medically related procedures and practices.
Reviews and signed Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communication.
Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center. Serves as a member of the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, which includes preparation of monthly reports and periodic conference calls.
Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis. Responds to calls from and provides instruction to Center Medical Staff with donor suitability questions. Conducts confidential and effective interviews with donors to obtain information in a variety of situations. Interviews donors with positive STS/negative FTA and documents approval to resume donating.
Maintains confidentiality with respect to employee, donor and center records reviewed during the course of all duties. Responsible for overseeing maintenance of medical supplies ad other emergency equipment.
Reviews and sings moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews abnormal test results including abnormal serum protein electrophoresis (SPE) test results and donor record lc-PD-09195 Page 2 files. Reviews normal SPE test results following an abnormal one and documents approval to resume donating.
Assures the health and safety of donors participating in the non-red blood cell immunization programs, if applicable. Monitors donor clinical response to immunizations, when applicable. Oversees hyper-immune programs, if applicable. For red cell recipients in the Anti-D Program, if applicable: Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment; provides review and approval for red blood cell immunization; is present when red cell immunizations are given. Submits monthly report to Divisional (or Corporate) Medical Director.
Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director. Maintains current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.)
May perform Center Physician functions including but not limited to notifying donors of unsuitable test results, performing screening medical evaluations, assessing results of donor screening and laboratory tests to determine a donor’s initial and continued suitability for plasmapheresis, explaining informed consent materials to donors.
Performs additional services as and when requested by the company.
Education
MD or DO degree from an accredited medical or osteopathic school. Must maintain a current and active medical license in the state in which the Center is located.
Experience
One year of residency training as an MD or OD.
Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA).
Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations and monitors medical compliance of the center. Either serves as or delegates to another appropriate physician the duties of “laboratory director”, “technical consultant”, or “clinical consultant” as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA). Assures that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
Reviews, understands, and complies with all CSL Plasma Services policies and procedures in the performance of services. Maintains high medical standards and ensures that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities. Is physically present at the center for agreed upon hours.
Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate. Trains other physicians. Evaluates newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs. Functionally directs the Center Medical Staff. Provides training to other center staff on medically related procedures and practices.
Reviews and signed Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communication.
Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center. Serves as a member of the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, which includes preparation of monthly reports and periodic conference calls.
Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis. Responds to calls from and provides instruction to Center Medical Staff with donor suitability questions. Conducts confidential and effective interviews with donors to obtain information in a variety of situations. Interviews donors with positive STS/negative FTA and documents approval to resume donating.
Maintains confidentiality with respect to employee, donor and center records reviewed during the course of all duties. Responsible for overseeing maintenance of medical supplies ad other emergency equipment.
Reviews and sings moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews abnormal test results including abnormal serum protein electrophoresis (SPE) test results and donor record lc-PD-09195 Page 2 files. Reviews normal SPE test results following an abnormal one and documents approval to resume donating.
Assures the health and safety of donors participating in the non-red blood cell immunization programs, if applicable. Monitors donor clinical response to immunizations, when applicable. Oversees hyper-immune programs, if applicable. For red cell recipients in the Anti-D Program, if applicable: Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment; provides review and approval for red blood cell immunization; is present when red cell immunizations are given. Submits monthly report to Divisional (or Corporate) Medical Director.
Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director. Maintains current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.)
May perform Center Physician functions including but not limited to notifying donors of unsuitable test results, performing screening medical evaluations, assessing results of donor screening and laboratory tests to determine a donor’s initial and continued suitability for plasmapheresis, explaining informed consent materials to donors.
Performs additional services as and when requested by the company.
Education
MD or DO degree from an accredited medical or osteopathic school. Must maintain a current and active medical license in the state in which the Center is located.
Experience
One year of residency training as an MD or OD.
Mar 30, 2020
Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA).
Serves as the primary physician for reporting to the Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations and monitors medical compliance of the center. Either serves as or delegates to another appropriate physician the duties of “laboratory director”, “technical consultant”, or “clinical consultant” as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA). Assures that CLIA/COLA training, CLIA/COLA proficiency testing for hematocrit and total protein, and signed of logs involving standardization takes place.
Reviews, understands, and complies with all CSL Plasma Services policies and procedures in the performance of services. Maintains high medical standards and ensures that cGMPs are adhered to through involvement with center management, center quality unit, and overall center activities. Is physically present at the center for agreed upon hours.
Provides medical oversight to Medical Staff Associates, including their training, although such training may be delegated to an approved Medical Staff Associate. Trains other physicians. Evaluates newly trained Medical Staff Associates for completion of training and recommendation for certification by Regulatory Affairs. Functionally directs the Center Medical Staff. Provides training to other center staff on medically related procedures and practices.
Reviews and signed Medical Staff Associates notebooks weekly, including a review of approximately one out of five screening medical evaluations and unsuitable test result communication.
Meets with Medical Staff Associates at least once a month to discuss medically related topics. Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center. Serves as a member of the Quality Assurance Team. Acts as a liaison between the Corporate or Divisional Medical Director and the Center Medical Staff, which includes preparation of monthly reports and periodic conference calls.
Responds to questions and phone calls regarding donor suitability for long-term serial plasmapheresis. Responds to calls from and provides instruction to Center Medical Staff with donor suitability questions. Conducts confidential and effective interviews with donors to obtain information in a variety of situations. Interviews donors with positive STS/negative FTA and documents approval to resume donating.
Maintains confidentiality with respect to employee, donor and center records reviewed during the course of all duties. Responsible for overseeing maintenance of medical supplies ad other emergency equipment.
Reviews and sings moderate and severe medical incident reports prior to donor being permitted to resume donating. Reviews abnormal test results including abnormal serum protein electrophoresis (SPE) test results and donor record lc-PD-09195 Page 2 files. Reviews normal SPE test results following an abnormal one and documents approval to resume donating.
Assures the health and safety of donors participating in the non-red blood cell immunization programs, if applicable. Monitors donor clinical response to immunizations, when applicable. Oversees hyper-immune programs, if applicable. For red cell recipients in the Anti-D Program, if applicable: Performs qualifying evaluation (e.g. administers consents, medical history and physical exam) on donors before enrollment; provides review and approval for red blood cell immunization; is present when red cell immunizations are given. Submits monthly report to Divisional (or Corporate) Medical Director.
Determines donor suitability following adverse reactions in consultation with the Corporate or Divisional Medical Director. Maintains current knowledge of infectious disease markets (i.e. HIV, HBV, HCV, syphilis, etc.)
May perform Center Physician functions including but not limited to notifying donors of unsuitable test results, performing screening medical evaluations, assessing results of donor screening and laboratory tests to determine a donor’s initial and continued suitability for plasmapheresis, explaining informed consent materials to donors.
Performs additional services as and when requested by the company.
Education
MD or DO degree from an accredited medical or osteopathic school. Must maintain a current and active medical license in the state in which the Center is located.
Experience
One year of residency training as an MD or OD.
Responsible for preparing the donor, donor area and equipment for the pheresis process.
1 Prepares the autopheresis machine for the pheresis process. 2 Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. 3 Disconnects the donor when the process is complete. 4 Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. 5 Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 6 Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor. 7 Alerts Group Leader or Supervisor of donor flow issues. 8 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs). 9 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 10 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 11 Maintains confidentiality of all personnel, donor and center information. 12 May be cross-trained in other areas to meet the needs of the business. 13 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 14 Perform job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months’ work experience, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions (physical & mental requirements) • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs
Mar 30, 2020
Responsible for preparing the donor, donor area and equipment for the pheresis process.
1 Prepares the autopheresis machine for the pheresis process. 2 Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. 3 Disconnects the donor when the process is complete. 4 Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff. 5 Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 6 Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor. 7 Alerts Group Leader or Supervisor of donor flow issues. 8 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs). 9 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 10 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 11 Maintains confidentiality of all personnel, donor and center information. 12 May be cross-trained in other areas to meet the needs of the business. 13 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 14 Perform job-related duties as assigned. Education • High school diploma or equivalent required Experience • Minimum of three (3) months’ work experience, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Working Conditions (physical & mental requirements) • Ability to understand, remember and apply oral and/or written instructions • Ability to understand and follow basic instructions and guidelines • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs
Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations. Provides limited emergency medical care to donors and staff, including the administration of medication or treatments in accordance with licensure or certification.
1 Promotes positive customer relations with all donors. 2 Conducts confidential and effective interviews with donors to obtain necessary information regarding suitability to donate plasma. 3 In conjunction with the Center Medical Director and/or Center Physician responds to medically related questions from staff including donor suitability and provides information to staff on medically related issues. 4 Performs medical history reviews and health assessments on donors. Assesses results of donor screening and laboratory tests to determine initial and continuing donor suitability. 5 Notifies and counsels donors regarding reactive test results. Refers donors to community facilities for follow-up and counseling. 6 Explains informed consent to applicant donors. This includes explanation of procedures, hazards and potential adverse events; explanation of immunization schedules, dose and antibody response; providing clear opportunity for donor to refuse participation; obtaining signature and date certifying informed consent. 7 Handles medical emergencies at the Center by providing routine care as outlined in Standard Operating Procedures (SOPs); elevates situations to Center Physician or local medical service providers as required. Periodically checks emergency kits to assure supplies are present and in-date. 8 Reviews test results and determines continued donor suitability. Follows SOPs regarding acceptable ranges of four-month required test (PE/STS) reports. Maintains knowledge of and apply all rules regarding four-month approvals and grace periods. 9 Assess signs and symptoms a donor may exhibit that may result in the inability to continue donating. 10 Manages employee hepatitis B and influenza immunization program, including administration of immunizations. 11 Understands the policies and procedures associated with hyper immune programs at the center where applicable, and oversees donor immunization programs. Reviews antibody titer results as required. Maintains awareness of appropriate immunization schedule for each antigen. 12 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 13 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation. 14 Maintains confidentiality of all personnel, donor and center information. 15 May be cross-trained in other areas to meet the needs of the business. 16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 17 Perform other job-related duties as assigned.
Education • Graduation from a paramedic, nursing, physician assistant, chiropractic, medical school or naturopathic medical training program • If graduation is from a foreign allopathic or osteopathic medical school, must also currently be licensed as a physician or state certification as an emergency medical technician
Experience • Minimum of one (1) year experience in a health care environment • Experience in a plasma or whole blood collection center or other regulated environment preferred • Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc. • Ability to instruct donors, staff and community regarding the benefit of plasma donation programs
Working Conditions (physical & mental requirements) • Ability to make decisions, which have moderate impact on immediate work unit. • Ability to understand, remember and apply oral and/or written instructions • Must be able to see and speak with customers and observe equipment operation • Occasionally perform tasks while standing and walking up to 100% of time • Examine and assess the skin and other abnormalities through sight, touch and smell • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs
Mar 30, 2020
Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations. Provides limited emergency medical care to donors and staff, including the administration of medication or treatments in accordance with licensure or certification.
1 Promotes positive customer relations with all donors. 2 Conducts confidential and effective interviews with donors to obtain necessary information regarding suitability to donate plasma. 3 In conjunction with the Center Medical Director and/or Center Physician responds to medically related questions from staff including donor suitability and provides information to staff on medically related issues. 4 Performs medical history reviews and health assessments on donors. Assesses results of donor screening and laboratory tests to determine initial and continuing donor suitability. 5 Notifies and counsels donors regarding reactive test results. Refers donors to community facilities for follow-up and counseling. 6 Explains informed consent to applicant donors. This includes explanation of procedures, hazards and potential adverse events; explanation of immunization schedules, dose and antibody response; providing clear opportunity for donor to refuse participation; obtaining signature and date certifying informed consent. 7 Handles medical emergencies at the Center by providing routine care as outlined in Standard Operating Procedures (SOPs); elevates situations to Center Physician or local medical service providers as required. Periodically checks emergency kits to assure supplies are present and in-date. 8 Reviews test results and determines continued donor suitability. Follows SOPs regarding acceptable ranges of four-month required test (PE/STS) reports. Maintains knowledge of and apply all rules regarding four-month approvals and grace periods. 9 Assess signs and symptoms a donor may exhibit that may result in the inability to continue donating. 10 Manages employee hepatitis B and influenza immunization program, including administration of immunizations. 11 Understands the policies and procedures associated with hyper immune programs at the center where applicable, and oversees donor immunization programs. Reviews antibody titer results as required. Maintains awareness of appropriate immunization schedule for each antigen. 12 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 13 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation. 14 Maintains confidentiality of all personnel, donor and center information. 15 May be cross-trained in other areas to meet the needs of the business. 16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 17 Perform other job-related duties as assigned.
Education • Graduation from a paramedic, nursing, physician assistant, chiropractic, medical school or naturopathic medical training program • If graduation is from a foreign allopathic or osteopathic medical school, must also currently be licensed as a physician or state certification as an emergency medical technician
Experience • Minimum of one (1) year experience in a health care environment • Experience in a plasma or whole blood collection center or other regulated environment preferred • Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc. • Ability to instruct donors, staff and community regarding the benefit of plasma donation programs
Working Conditions (physical & mental requirements) • Ability to make decisions, which have moderate impact on immediate work unit. • Ability to understand, remember and apply oral and/or written instructions • Must be able to see and speak with customers and observe equipment operation • Occasionally perform tasks while standing and walking up to 100% of time • Examine and assess the skin and other abnormalities through sight, touch and smell • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs
Responsible for the efficient and effective collection of plasma by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs).
1 In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect. 2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process. 3 Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor. 4 May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. 5 Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff. 6 Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 7 Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues. 8 Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service. 9 Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader of Supervisor of donor flow issues. 10 Collects arm samples or whole blood samples from donors for testing. 11 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs). 12 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 13 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 14 Maintains confidentiality of all personnel, donor and center information. 15 May be cross-trained in other areas to meet the needs of the business. 16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 17 Perform other job-related duties as assigned. Education • High school diploma or equivalent required. Experience • Minimum twelve (12) months experience in a medical or health care environment preferred or equivalent combination of education and experience. Working Conditions (physical & mental requirements) • Ability to complete routine forms or conduct routine oral communications • Ability to understand, remember and apply oral and/or written instructions • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens. • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs
Mar 30, 2020
Responsible for the efficient and effective collection of plasma by performing venipuncture, monitoring the pheresis process and following Standard Operating Procedures (SOPs).
1 In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect. 2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process. 3 Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor. 4 May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. 5 Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff. 6 Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events. 7 Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues. 8 Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service. 9 Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader of Supervisor of donor flow issues. 10 Collects arm samples or whole blood samples from donors for testing. 11 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs). 12 Understands the policies and procedures associated with hyper immune programs at the center if applicable. 13 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. 14 Maintains confidentiality of all personnel, donor and center information. 15 May be cross-trained in other areas to meet the needs of the business. 16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. 17 Perform other job-related duties as assigned. Education • High school diploma or equivalent required. Experience • Minimum twelve (12) months experience in a medical or health care environment preferred or equivalent combination of education and experience. Working Conditions (physical & mental requirements) • Ability to complete routine forms or conduct routine oral communications • Ability to understand, remember and apply oral and/or written instructions • Must be able to see and speak with customers and observe equipment operation. • Occasionally perform tasks while standing and walking up to 100% of time • Reach, bend, kneel and have high level of manual dexterity • Occasionally be required to lift and carry up to 25 pounds • Fast paced environment with frequent interruptions • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens. • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Required to work overtime and extended hours to support center operational needs
This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
• Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level
1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.
2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.
5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.
8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.
9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation.
10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.
11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.
12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.
13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.
14 Follow all Standard Operating Procedures (SOPs), company policies and procedures.
15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.
16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.
17 Assist Plasma center staff in completing other special projects or assignments, as requested.
18 Perform other job-related duties, as assigned.
Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience
• Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.
• Strong customer service skills
• Strong critical reasoning, decision-making and problem solving skills to analyze situations
• Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
• Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements)
• Occasionally required to work with the public when they are dissatisfied
• 80% of the time standing and walking and 20% of the time sitting
• Reach, bend, kneel and have high level of manual dexterity
• See and speak with customers and observe equipment operation
• Occasionally be required to lift and carry 25 lbs.
• Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors
Mar 30, 2020
This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
• Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level
1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.
2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.
5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.
8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.
9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation.
10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.
11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.
12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.
13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.
14 Follow all Standard Operating Procedures (SOPs), company policies and procedures.
15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.
16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.
17 Assist Plasma center staff in completing other special projects or assignments, as requested.
18 Perform other job-related duties, as assigned.
Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience
• Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.
• Strong customer service skills
• Strong critical reasoning, decision-making and problem solving skills to analyze situations
• Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
• Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements)
• Occasionally required to work with the public when they are dissatisfied
• 80% of the time standing and walking and 20% of the time sitting
• Reach, bend, kneel and have high level of manual dexterity
• See and speak with customers and observe equipment operation
• Occasionally be required to lift and carry 25 lbs.
• Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors
