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About the role
Key responsibilities & impact- Lead the commercial legal function with primary responsibility to support the expected first U.S. product launch
- Serve as a trusted strategic partner and providing practical, timely and business-savvy legal advice to the Commercial (Sales, Marketing, Market Access), Medical Affairs, and Patient Support functions
- Subject matter expert (SME) on U.S. healthcare laws, FDA promotional regulations and industry codes to enable legal and compliant pre-launch, launch and ongoing commercial and medical activities
- Partner with Compliance to ensure that the Company’s U.S. compliance program remains risk-based, fit-for-purpose and aligned with corporate values
- Support cross-functional teams through advisory responsibilities, training and policy development
Requirements
What you’ll need- JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech preferred)
- Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, and industry codes, and ability to stay current on evolving trends and enforcement
- Experience reviewing promotional and medical materials
- Ability to interpret and apply healthcare laws to complex business plans
- Experience supporting product launch planning and cross functional review committees (experience building for first US launch preferred)
- Strong business partnering skills with ability to balance risk and business goals
- Excellent communication skills
- Ability to manage multiple priorities in a fast-paced environment; comfortable working in a demanding start-up culture with evolving processes; flexible and able to adapt to new situations as the business demands
Benefits
Comp & perks- Competitive medical, dental, and vision benefits
- PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Subsidized daily lunches and snacks at our on-site locations
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
U.S. Healthcare LawsFDA Promotional RegulationsAnti-Kickback StatuteFalse Claims ActOIG GuidanceReviewing Promotional MaterialsInterpreting Healthcare LawsCross-Functional Review CommitteesPolicy DevelopmentRisk Management
Soft Skills
Excellent Communication SkillsAbility to Manage Multiple PrioritiesAdaptabilityBusiness SavvyTeam Collaboration