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Associate Director, Worldwide Medical, Established Brands Portfolio - Princeton New Jersey
Company: Disability Solutions Location: Princeton, New Jersey
Posted On: 05/04/2024
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 .Position SummaryThe Established Brands Associate Director is responsible for strategy and execution of medical affairs-related activities for brands in the Established Brands portfolio, with focus on the Hematology and Oncology therapeutic area.Key Responsibilities - Working closely with the Team Lead and the Worldwide Established Brands team, provide medical oversight and manage WW medical activities for the Hematology and Oncology brands within the expanding Established Brands Organization.
- Lead global medical activities in support of strategic execution of plans in regions where brand continues to be actively commercialized and develop and execute medical strategy for expansion into new markets.
- Provide medical assessments of risk/benefit of assigned products regarding new indications, safety or stability/quality issues, medical necessity/sensitivity assessments or other actions that require reappraisal of the product Risk/Benefit.
- Partner with medical subject-matter experts from WW Hematology and Oncology Therapeutic Area teams and Market medical teams to provide strategic input to Loss-of-Exclusivity planning and transition to Established Brands portfolio.
- Work closely with key cross-functional matrix partners: Commercial, Regulatory, Safety, Labeling, Supply & Manufacturing, Quality & Compliance to support brand activities (e.g., labeling, safety, quality, deletions).
- Lead medical insight at cross-functional teams, including revaluation of WW medical content, local market needs, and labeling recommendations based on proactive signal detection activities.
- Provide medical input for regulatory requirements including response to Health Authorities queries, support for registration renewals and label periodic reviews.
- Provide medical support and input to the CCDS content review and development.
- Provide medical evaluation and appropriate communications to additional documents and activities such as: Dear Health Care Professional letters, Clinical Overview for Type II variation and coordinate expert reports.
- Provide clinical trial expertise for new evidence generation needs or health-authority commitment studies.
- Compliance Support delivery of medical affairs compliance needs for the assigned portfolio, as appropriate.
- Demonstrate ability to apply BMS operating philosophy and operate within company policies and procedures and appropriate regulations.
- Management, as appropriate, of the budget allocated to the specific projects.Qualifications & Experience
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