Legal Counsel, Therapeutic Area Products
Core
Provide US and global legal advice and support across the lifecycle of innovative medicines, covering commercial, medical affairs, market access, and government affairs.
Role type
Senior in-house legal counsel (therapeutic area products)
Builds
Legal strategies and compliance frameworks for biotech product commercialization
Domain
Life sciences / Biotechnology / Healthcare Law
Required skills
US law license, healthcare fraud and abuse law expertise, FDA regulatory knowledge, antitrust law, products liability, privacy law, contract negotiation, training development
Preferred skills
Therapeutic area product support experience, biotech/pharma industry knowledge
Technologies
Legal research databases, contract management systems
Responsibilities
Advise on FDA submissions, label negotiations, and data use; counsel on relationships with healthcare professionals and government entities; develop compliance training; negotiate with co-promotion partners; lead cross-functional product initiatives
Seniority
Senior, hands-on IC