Assistant General Counsel - Government Programs
Sanofi
August 16, 2026
Remote friendly (Cambridge, MA)
United States
$206,250 - $297,916.66 USD yearly
Corporate Functions
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).
Application Instructions
- Not provided in the text.
- 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).
Application Instructions
- Not provided in the text.