Associate Director, Legal Compliance
About The Position
The Associate Director, Legal Compliance serves as a trusted strategic partner to the Commercial, Medical Affairs, Market Access, and Patient Support functions. This role provides subject matter expertise on U.S. healthcare laws, FDA promotional regulations, and industry codes to enable compliant launch readiness and ongoing commercialization activities for the assigned product. The role ensures that the Company’s U.S. compliance program remains risk-based, fit-for-purpose, and aligned with corporate values, while supporting cross-functional teams through advisory responsibilities, training, and policy development.
Requirements
- Bachelor’s and JD required.
- A minimum of 10+ years of relevant legal/compliance experience. Biotechnology experience strongly preferred.
- Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG guidance, and industry codes.
- Experience providing legal or compliance support to Commercial, Medical Affairs, Market Access, and/or Patient Support functions.
- Experience reviewing promotional and medical materials as a Legal or Compliance reviewer.
- Ability to interpret and apply healthcare laws to complex business activities.
Nice To Haves
- Experience in commercial and medical compliance in a pharmaceutical environment.
- Experience supporting product launch planning and cross-functional review committees.
- Strong business partnering orientation with ability to balance risk and business goals.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities in a fast-paced environment.
Responsibilities
- Serve as trusted business partner and SME to commercial and medical teams
- Advise on launch strategy, disease awareness, marketing campaigns, patient programs
- Act as Legal representative on Promotional Review Committee, Medical Review Committee, ISR reviews, grants and sponsorships committees
- Advise patient support team on hub services, reimbursement programs
- Counsel market access on PIE, FDAMA 114; draft and review commercial and patient support agreements
- Provide legal advice to commercial, medical, and advocacy teams on compliance obligations
- Support Compliance to evolve the U.S. compliance program to remain right‑sized and aligned with company values.
- Prepare and deliver training on compliance responsibilities, ethics, policies, and procedures.
- Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes.
- Coordinate legal support as a cross-functional partner with business and Law Department colleague
- Other duties and responsibilities as assigned.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
