We are seeking an Associate Director, Global Labeling Lead to lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products.
Requirements
- Define and execute Labeling strategy for global life cycle management of medicinal products in BioNTech's responsibility for Primary Reference Labeling (i.e., the Company Core Data Sheet (CCDS), US Prescribing Information (USPI) and EU CP Summary of Product Characteristics [SmPC])
- Build and lead cross-functional Labeling Teams
- Responsible for timely preparation of Primary Reference labeling updates following update of the CCDS or on request of competent Health Authorities
- Ensure timely communication of updated CCDS content to local country offices for MAs in BioNTech’s responsibility
- Lead development and maintenance of regulatory processes and systems for Global Labeling
- Identify critical Regulatory Labeling issues and proactively implement activities for their resolution including leading initiatives for Labeling within GRA or across functions at BioNTech
- Act as the empowered delegate for the Head of Global Labeling as necessary
Benefits
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
