Associate General Counsel (Commercial)
New
Role can support remote-based candidatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 12+ years of relevant legal experience
Requirements
- JD required.
- 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.
- 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.
- Strong business partnering skills with ability to balance risk and business goals.
- Ability to manage multiple priorities in a fast-paced environment.
- Comfortable working in a demanding start-up culture.
Responsibilities
- Serve as key legal partner and SME to commercial and medical teams.
- Provide practical legal advice on pre-launch activities and launch strategy, including medical affairs, disease awareness, and sales/marketing.
- Counsel market access on pricing, reimbursement, distribution, and contracting structures.
- Act as legal representative on promotional, medical, and publications review committees.
- Oversee outside counsel and manage legal diligence for financings and business development.
- Partner with Compliance to evolve the U.S. compliance program and support the development of policies and SOPs related to healthcare regulations.
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