Assistant General Counsel – 340B

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 the 340B Credit Model.
- Manage 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 authority/enforcement, and manufacturer obligations).
- Counsel senior leadership on 340B-related risks, litigation strategy, regulatory developments, and policy options.
- Act as primary legal point of contact for cross-functional teams to ensure an integrated, coherent 340B legal strategy.
- Monitor and analyze industry-wide 340B litigation and advise on implications.

PhRMA & Industry Engagement
- Represent Sanofi in PhRMA working groups and industry forums on 340B reform and government pricing.
- Collaborate with Government Affairs/Public Policy on federal/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 obligations.

Qualifications
Basic
- J.D. (ABA-accredited) and active bar membership (U.S. jurisdiction).
- 10+ years as a practicing attorney in healthcare law, pharmaceutical pricing, government price reporting, or related field.
- Deep 340B expertise (contract pharmacy, duplicate discounts, diversion, HRSA oversight, ADR).
- Experience managing/supporting complex federal litigation involving HHS/HRSA/CMS.
- Strong knowledge of MDRP, AMP, Best Price, ASP, and FSS/VA pricing.

Preferred
- Government experience (HHS/HRSA/CMS/DOJ or state Medicaid), especially 340B administration/enforcement/litigation.
- In-house legal experience or equivalent law firm experience for pharmaceutical clients.
- Direct experience with 340B integrity initiatives and credit/rebate model design/implementation.
- Experience with PhRMA/industry coalitions on 340B/government pricing.
- Familiarity with state 340B protection and drug price transparency requirements.
- Experience with Anti-Kickback Statute, False Claims Act, and healthcare fraud/abuse laws (government pricing/market access).
- Excellent oral/written communication; leadership and ability to manage multiple priorities; strong learning agility; collaborative mindset.