Main Responsibilities
- Serve as lead in-house counsel on all legal matters arising from the 340B Integrity Initiative.
- Provide day-to-day legal oversight and strategic direction for Sanofi’s 340B Credit Model.
- Manage all federal and state litigation, investigations, and enforcement actions implicating Sanofi’s 340B practices.
- Manage and coordinate all 340B HRSA Administrative Dispute Resolution (ADR) proceedings.
- Monitor, analyze, and advise on federal and state legislative and regulatory developments relating to 340B.
- Advise on 340B intersections with MDRP, FSS, and Medicare Part B (duplicate discount prevention, Best Price implications, and ceiling price calculations).
- Develop and maintain legal positions on key 340B interpretive questions (covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, HRSA oversight/enforcement, and manufacturer obligations).
- Provide strategic counsel to senior leadership on 340B risks, litigation strategy, regulatory developments, and policy options.
- Serve as primary legal point of contact for cross-functional teams; ensure legal strategy is integrated into business decisions.
- Monitor and analyze industry-wide 340B litigation and advise on implications for Sanofi’s strategy and risk.
PhRMA & Industry Engagement
- Represent Sanofi in PhRMA working groups/coalitions/forums; coordinate positions with industry peers.
- Collaborate with Government Affairs/Public Policy on federal and state 340B reform positions.
- Engage with HRSA, CMS, HHS OIG, and state Medicaid agencies to educate and advocate for integrity reforms.
- Train commercial/market access/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 at least one U.S. jurisdiction.
- 10+ years’ experience in healthcare law, pharmaceutical pricing, government price reporting, or related field.
- Deep expertise in 340B (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 (HHS/HRSA/CMS/DOJ or state Medicaid), especially 340B administration, enforcement, or litigation.
- In-house or equivalent law firm experience advising on 340B/government pricing.
- Direct experience with 340B integrity initiatives, claims data programs, or credit/rebate model design/implementation.
- Experience engaging PhRMA/industry coalitions on 340B/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 pricing/market access context.
- Excellent oral/written communication; ability to present complex issues clearly.
- Ability to manage multiple high-priority matters; strong leadership and cross-functional influence; learning agility.
Benefits (if explicitly stated)
- Comprehensive benefits including medical/dental/vision insurance, 401(k) match, paid time off, short- and long-term incentives, and well-being resources; at least 14 weeks’ gender-neutral parental leave.
Application Instructions
- Not provided in the text.