Responsibilities:
- Serve as a key legal advisor on US commercial activities for vaccines, focusing on advising on the promotional, sale, and distribution of vaccines to public and private entities.
- Provide primary legal support related to contracts for the sale of vaccines to government entities.
- Act as a brand lawyer/product support lead, advising on promotional and non-promotional initiatives across a highly matrixed organization; use expertise in FDA advertising and promotion and fraud/abuse; issue-spot and collaborate with legal subject matter experts.
- Counsel on the external legal environment for operating a vaccines business with understanding of industry practices.
- Partner with cross-functional and matrix teams (e.g., Medical Affairs, Communications, Commercial Operations, Regulatory, Supply) and communicate complex information clearly.
- Partner with Compliance to ensure Policies/SOPs are fit-for-purpose and that training supports adherence.
- Manage outside counsel in limited circumstances.
Basic Qualifications:
- U.S. Juris Doctor (J.D.)
- Current member of a state bar
- Minimum 7 years relevant experience
- Experience in US FDA promotional laws/regulations
- Working knowledge of commercialization of pharmaceuticals or vaccines
Preferred Qualifications:
- Government contracting experience involving sale of pharmaceuticals or vaccines