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. The role focuses on U.S. legal advice within the Global Rare Business Unit (GRBU), with potential involvement in global or international legal matters related to promotional and medical materials, initiatives, and strategies. This position is hybrid and primarily located 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 company policies/guidelines
- Analyze U.S. and global materials, initiatives, and training related to advertising & 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; advise relevant teams
- Partner with the compliance team on policy setting, training, and other activities
- Collaborate with legal colleagues to support general corporate and R&D legal 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 drug experience is a plus
- Ability to work collaboratively with a wide range of colleagues and external parties
- Ability to make thoughtful, integrated, timely decisions and take appropriate actions
- Experience managing outside counsel for specialized projects
- Ability to manage multiple tasks independently in a fast-paced environment
- Strong organizational skills and attention to detail
Skills
- Healthcare regulatory compliance knowledge, especially advertising and promotion, and fraud and abuse laws
- Strategic thinking and risk assessment
- Effective collaboration and communication with cross-functional teams
- IP and corporate/R&D law fundamentals
Education
- Bachelorโs Degree
- Juris Doctor (JD) from an accredited U.S. law school
Additional Requirements
- Hybrid work arrangement with location in Cambridge, MA