Unknown Company

Assistant General Counsel - Government Programs

cambridge, ma • Posted 1 weeks ago
Onsite Contract Corporate Law

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 HRSA Administrative Dispute Resolution (ADR) proceedings.
  • Monitor, analyze, and advise on federal and state legislative and regulatory developments relating to 340B.
  • Advise on intersection of 340B with MDRP, FSS, and Medicare Part B (duplicate discount prevention, Best Price implications, ceiling price calculations).
  • Develop and update legal positions on 340B interpretive questions (covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, HRSA oversight/enforcement, manufacturer obligations).
  • Provide strategic counsel to senior leadership on risks, litigation strategy, regulatory developments, and policy options.
  • Act as primary legal point of contact for cross-functional 340B matters.
  • Monitor and analyze industry-wide 340B litigation and advise on implications.

PhRMA & Industry Engagement

  • Represent Sanofi in PhRMA working groups/coalitions; coordinate positions with industry peers.
  • Partner with Government Affairs/Public Policy on federal and state 340B legislative/regulatory positions.
  • Engage HRSA, CMS, HHS OIG, and state Medicaid agencies; advocate for program integrity reforms.
  • Train commercial, market access, and compliance teams on 340B legal requirements, Credit Model, ADR, and compliance obligations.

About You

Basic Qualifications:

  • J.D. (ABA-accredited); active bar membership in good standing.
  • 8+ years’ experience 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 Qualifications:

  • Government experience with 340B administration/enforcement/litigation.
  • In-house or equivalent law firm experience advising on 340B/government pricing.
  • Experience with 340B integrity initiatives, claims data programs, or credit/rebate model design.
  • Experience engaging PhRMA/industry coalitions on 340B or pricing policy.
  • Familiarity with state 340B protection and transparency reporting requirements.
  • Experience with Anti-Kickback Statute, False Claims Act, and healthcare fraud/abuse laws in pricing context.
  • Strong communication; ability to manage multiple high-priority matters; leadership presence; learning agility; collaborative mindset.

Benefits

  • Comprehensive benefits package (medical, dental, vision; 401(k) match; paid time off; short- and long-term incentives; well-being/support resources).

#J-18808-Ljbffr

Assistant General Counsel - Government Programs in cambridge at Unknown Company

This position is listed as contract and onsite.

Back to Job Search