Main Responsibilities
- Serve as lead in-house counsel on all legal matters arising from Sanofi’s 340B Integrity Initiative.
- Provide day-to-day legal oversight and strategic direction for Sanofi’s 340B Credit Model.
- Manage federal and state litigation, investigations, and enforcement actions relating to Sanofi’s 340B practices.
- Manage and coordinate HRSA Administrative Dispute Resolution (ADR) proceedings.
- Monitor, analyze, and advise on federal and state legislative and regulatory developments relating to 340B.
- Advise on 340B intersection with MDRP, FSS, and Medicare Part B (duplicate discount prevention, Best Price, and ceiling price calculations).
- Develop and regularly update legal positions on interpretive issues (covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, HRSA oversight/enforcement, and manufacturer obligations).
- Advise senior leadership on 340B risks, litigation strategy, regulatory developments, and policy options.
- Act as primary legal point of contact for cross-functional teams to integrate legal strategy into business decisions.
- Monitor and analyze industry-wide 340B litigation and assess implications for Sanofi.
PhRMA & Industry Engagement
- Represent Sanofi in PhRMA working groups/coalitions and advance Sanofi’s legal and policy perspectives.
- Collaborate with Government Affairs/Public Policy to develop federal and state 340B reform positions.
- Engage with HRSA, CMS, HHS OIG, and state Medicaid agencies to advocate for program integrity reforms.
- Train commercial, market access, and compliance teams on 340B legal requirements, the Credit Model, ADR, and related compliance obligations.
Basic Qualifications
- J.D. from an ABA-accredited law school; active bar membership in good standing in at least one U.S. jurisdiction.
- Minimum 10 years’ experience in healthcare law, pharmaceutical pricing, government price reporting, or closely related field.
- Deep 340B expertise (contract pharmacy, duplicate discounts, diversion, HRSA oversight, ADR).
- Experience managing/supporting complex federal litigation involving HHS, HRSA, or CMS.
- Strong knowledge of MDRP, AMP, Best Price, ASP, and FSS/VA pricing.
Preferred Qualifications
- Government experience with 340B administration/enforcement/litigation.
- In-house legal experience (pharma/biotech) or equivalent law firm experience advising on 340B and government pricing.
- Experience with 340B integrity initiatives, claims data programs, or credit/rebate model design/implementation.
- Engagement experience with PhRMA/industry coalitions on 340B or government pricing policy.
- Familiarity with state 340B protection statutes and drug price transparency reporting.
- Experience with Anti-Kickback Statute, False Claims Act, and healthcare fraud/abuse laws in government pricing/market access context.
- Strong oral/written communication; ability to manage multiple high-priority matters.
Benefits (explicitly stated)
- Medical, dental, vision; 401(k) with company match; paid time off; short- and long-term incentive programs; well-being and employee support resources; at least 14 weeks’ gender-neutral parental leave.