The Senior Manager, US Commercial & Healthcare Compliance role will play an instrumental part in the development and execution of the US Commercial Compliance Program in support of the US Commercial Team as BioNTech transforms from a primarily research and development organization, into a commercial pharmaceutical company focused on oncology, infectious disease, and other severe diseases.
Requirements
- Bachelor’s degree required, 5 plus years of legal, compliance, audit, or commercial experience, of which at least 3 years in the healthcare, medical device or pharmaceutical industries.
- Experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, False Claims Act, Anti-Kickback Statute, the US Food, Drug, & Cosmetic Act, the Stark Law, and the US Federal Sentencing Guidelines.
- Experience executing compliance monitoring in the medical device or pharmaceutical industries.
- Solid understanding of compliance risks in the context of products governed by the US Food, Drug & Cosmetic Act.
- Experience interacting and collaborating with global colleagues.
- Ability to lead and facilitate discussions with senior leaders at the country and global levels.
- Ability to work independently and deliver on deadlines while managing multiple projects and priorities and ability to work with multiple systems, analytical tools, databases, and reporting platforms.
- Proven ability to successfully collaborate with cross-functional teams to identify needs, provide sound and accurate compliance guidance and communicate solutions.
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
