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Associate Director, Advertising & Promotion Commercial Regulatory Affairs - Princeton New Jersey
Company: Disability Solutions Location: Princeton, New Jersey
Posted On: 05/03/2024
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .Summary:The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met. Individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.Responsibilities include: - 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:
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