Role Summary
The Associate Legal Director, Commercial Counsel provides comprehensive legal support for marketed and late-stage clinical programs, partnering with marketing, sales, medical affairs, patient services, and market access teams. This role supports the Global Rare Business Unit (GRBU), with a focus on U.S. legal advice, in a hybrid role based in Cambridge, MA.
Responsibilities
- Provide comprehensive, high quality legal advice and support to U.S. commercial, medical affairs, patient services, and market access teams based on applicable laws and regulations (including fraud and abuse and anti-bribery laws) and internal policies
- Analyze U.S. and global materials, initiatives, and training related to advertising and promotion, disease awareness, patient support programs, and medical education
- Identify, analyze, and mitigate legal and commercial risks, engage and coordinate outside counsel for specialized advice, and advise relevant teams
- Partner with compliance on policy setting, training, and related activities
- Collaborate with legal colleagues to support general corporate and R&D matters and other legal projects as needed
Qualifications
- Bachelorโs Degree and Juris Doctor from an accredited U.S. law school; excellent academic credentials preferred
- Minimum 5โ7 years of legal experience
- Current bar admission for in-house practice
- Experience in pharma/biotech or healthcare-related matters; rare disease, specialty, or pediatric drugs a plus
- Ability to work collaboratively with internal teams and external parties
- Strong decision-making, communication, and project management skills
- Experience managing outside counsel for specialized projects
- Ability to manage multiple tasks in a fast-paced environment
- Strong organizational skills and attention to detail
Skills
- Healthcare regulatory knowledge (advertising, promotion, fraud and abuse, anti-bribery)
- Legal analysis of marketing materials and promotional activities
- Risk assessment and mitigation
- Cross-functional collaboration
- Effective communication with diverse stakeholders
Education
- Bachelorโs Degree
- Juris Doctor (J.D.) from an accredited U.S. law school
Additional Requirements
- Hybrid work arrangement; location: Cambridge, MA