Director, Product Counsel

The Director, Product Counsel, Legal and Compliance, serves as a trusted strategic partner and is responsible for providing practical and thoughtful legal counsel to the Commercial, Medical Affairs, Market Access, and Patient Support functions in support of assigned products. This role is the expected to be the subject matter expert on U.S. healthcare laws, FDA promotional regulations, and industry codes to enable compliant launch readiness and ongoing commercialization and medical activities for the assigned product. The role partners with Compliance to 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.Key ResponsibilitiesCommercial & Medical Affairs Legal Support (75%)Serve as key legal partner and SME to commercial and medical teams on established and launching productsProvide practical legal advice on launch strategy, disease awareness, marketing campaigns, patient programs, advisory boards, and all other business activities supporting the assigned productsAct as Legal representative on Promotional Review Committee, Medical Review Committee, ISR reviews, grants and sponsorships committees for established and launch productsCounsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub servicesCompliance Program Support (15%)Advise commercial, medical, and advocacy teams on compliance obligationsPartner with Compliance to evolve the U.S. compliance program to remain right‑sized and aligned with company valuesPrepare and deliver training on compliance responsibilities, ethics, policies, and proceduresSupport development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codesCross-Functional Legal Support (10%)Coordinate legal support as a cross-functional partner with business and Legal and Compliance colleaguesOther duties and responsibilities as assigned.