Associate Director, Established Brands

Role Summary

The Established Brands Associate Director, Medical Affairs, is responsible for leading and executing medical strategy and activities for brands within the expanding Established Brands portfolio. This role provides medical oversight, ensures scientific rigor, and supports regulatory and compliance needs, collaborating closely with cross-functional partners to ensure appropriate medical support for the maintenance and lifecycle management of mature pharmaceutical assets. The role also facilitates scientific exchange and provides medical information to healthcare professionals and stakeholders.

Responsibilities

• Partner with the team lead to support the development and execution of global medical affairs strategies for established brands, ensuring alignment with scientific, regulatory, and patient needs.
• Provide medical assessments of risk/benefit, safety, and quality issues for assigned products.
• Partner with Global 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, Marketing, Regulatory, Medical Information, 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 Global 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 existing evidence generation studies or health-authority commitment studies.
• Facilitate scientific exchange and provide medical information to healthcare professionals and stakeholders.
• Manage allocated project budgets as appropriate.

Qualifications

• MD, PharmD, PhD or Equivalent
• 3-5+ years of pharmaceutical industry experience, with notable medical affairs experience
• Excellent oral and written communication skills
• Demonstrate flexibility, open mindedness, and adaptability in a rapidly changing environment.
• Ability to promote collegiality and teamwork, as well as to think clearly and decisively when presenting independent, reasoned solutions to identified safety issues