Bristol Myers Squibb
Associate Director, Commercial Regulatory Affairs- Advertising and Promotion
Bristol Myers Squibb, Princeton, New Jersey, us, 08543
Overview
Associate Director, Commercial Regulatory Affairs- Advertising and Promotion
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Bristol Myers Squibb
seeks an experienced regulatory professional to advise on promotional materials and campaigns for an assigned product/therapeutic area, ensuring compliance with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.
Responsibilities
Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
Provides solution oriented and innovative advice to meet the Company's objectives and goals
Provide strategic advice for the development of Office Of Prescription Drug Promotion advisory submissions and sub part e submissions
Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances
Ensure regulatory compliance with sub part e and 2253 regulations
Lead training for Commercial teams on sub part e, 2253 regulations and FDA regulations on advertising and promotion
Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice
Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
Provide input on process improvement and BMS guiding principles as needed
Engages with colleagues within the department to help support them in their roles and development
Provide direct management to individuals depending on assignment
Proactively seeks opportunities to learn and develop leadership skills
Qualifications
BS required; advanced degree preferred (MS, PhD, PharmD, JD)
Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)
Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
Proven aptitude to analyze and interpret efficacy and safety data
Experience communicating and negotiating with OPDP
Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration
Excellent verbal, communication, and presentation skills
Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.
Compensation and Benefits The starting compensation for this job is a range from $173,350 - $210,100, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Benefits
Medical, pharmacy, dental and vision care
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP)
Financial well-being resources and a 401(K)
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two paid days to volunteer, sick time off, and summer hours flexibility
Parental, caregiver, bereavement, and military leave
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources
Other perks like tuition reimbursement and a recognition program
On-site and Work Model BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role. Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Legal
Industries: Pharmaceutical Manufacturing
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at
Bristol Myers Squibb
seeks an experienced regulatory professional to advise on promotional materials and campaigns for an assigned product/therapeutic area, ensuring compliance with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.
Responsibilities
Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
Provides solution oriented and innovative advice to meet the Company's objectives and goals
Provide strategic advice for the development of Office Of Prescription Drug Promotion advisory submissions and sub part e submissions
Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances
Ensure regulatory compliance with sub part e and 2253 regulations
Lead training for Commercial teams on sub part e, 2253 regulations and FDA regulations on advertising and promotion
Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice
Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
Provide input on process improvement and BMS guiding principles as needed
Engages with colleagues within the department to help support them in their roles and development
Provide direct management to individuals depending on assignment
Proactively seeks opportunities to learn and develop leadership skills
Qualifications
BS required; advanced degree preferred (MS, PhD, PharmD, JD)
Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)
Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
Proven aptitude to analyze and interpret efficacy and safety data
Experience communicating and negotiating with OPDP
Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration
Excellent verbal, communication, and presentation skills
Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.
Compensation and Benefits The starting compensation for this job is a range from $173,350 - $210,100, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Benefits
Medical, pharmacy, dental and vision care
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP)
Financial well-being resources and a 401(K)
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two paid days to volunteer, sick time off, and summer hours flexibility
Parental, caregiver, bereavement, and military leave
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources
Other perks like tuition reimbursement and a recognition program
On-site and Work Model BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role. Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
Job Details
Seniority level: Director
Employment type: Full-time
Job function: Legal
Industries: Pharmaceutical Manufacturing
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