Job title: Assistant General Counsel -Government Programs
Location: Washington, DC / Morristown, NJ/ Cambridge, MA
Travel: Up to 20%
Main Responsibilities:340B Integrity Initiative, Credit Model & Associated Legal ProceedingsThis is the core of the role. The successful candidate will be expected to develop and maintain deep, current expertise across all dimensions of Sanofi's 340B legal posture.- Serve as Sanofi's 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 and investigations or enforcement actions implicating Sanofi's 340B practices.
- Manage and coordinate all 340B HRSAAdministrative Dispute Resolution (ADR) proceedings
- Monitor, analyze, and advise on federal andstate legislative and regulatory developments relating to 340B
- Advise on the intersection of the 340B program with other federal government pricing programs, including the Medicaid Drug Rebate Program (MDRP), the Federal Supply Schedule (FSS), and Medicare Part B, with particular focus on duplicate discount prevention, Best Price implications, and the legal framework governing ceiling price calculations.
- Develop, maintain, and regularly update Sanofi's legal positions on key 340B interpretive questions, including covered entity eligibility, the patient definition, contract pharmacy arrangements, orphan drug exclusions, HRSA's oversight authority and enforcement powers, and the scope of manufacturer obligations under the 340B statute.
- Provide strategic legal counsel to senior leadership on 340B-related risks, litigation strategy, regulatory developments, and policy options, including preparing and presenting clear, actionable legal analyses and recommendations on high-stakes matters.
- Serve as the primary legal point of contact for cross-functional teams on all 340B-related matters, ensuring that legal strategy is integrated into business decision-making and that the company's 340B posture is coherent and defensible across all functions.
- Monitor and analyze industry-wide 340B litigation and advise on implications for Sanofi's legal strategy, positions, and risk profile.
PhRMA & Industry Engagement- Serve as Sanofi's primary legal representative in PhRMA working groups, coalitions, and industry forums focused on 340B reform, government pricing, and market access policy, including coordinating Sanofi's positions with industry peers and advancing Sanofi's legal and policy perspectives in those forums.
- Collaborate with Sanofi's Government Affairs and Public Policy teams to develop and advance Sanofi's legislative and regulatory positions on 340B reform at the federal and state levels, including engagement with Congress, HHS, HRSA, CMS, and relevant state agencies.
- Engage directly with government and regulatory agencies - including HRSA, CMS, HHS OIG, and state Medicaid agencies - to educate on the implications of specific policies, represent Sanofi's legal perspective, and advocate for program integrity reforms consistent with the original mission of the 340B program.
- Prepare and deliver training to Sanofi's commercial, market access, and compliance teams on 340B legal requirements, the Credit Model, ADR proceedings, and related compliance obligations.
About YouBasic Qualifications:- J.D. from an ABA-accredited law school; active bar membership in good standing in at least one U.S. jurisdiction
- Minimum 8 years of experience as a practicing attorney in healthcare law, pharmaceutical pricing, government price reporting, or a closely related field
- Demonstrated deep expertise in the 340B Drug Pricing Program, including contract pharmacy issues, duplicate discounts, diversion, HRSA oversight, and ADR proceedings
- Experience managing or supporting complex federal litigation involving HHS, HRSA, or CMS
- Strong knowledge of the Medicaid Drug Rebate Program, AMP, Best Price, ASP, and FSS/VA pricing
Preferred Qualifications:- Government experience (e.g., HHS, HRSA, CMS, DOJ, or state Medicaid agencies), particularly experience with 340B program administration, enforcement, or litigation
- In-house legal experience at a pharmaceutical or biotechnology company, or equivalent law firm experience advising pharmaceutical clients on 340B and government pricing matters
- Direct experience with 340B integrity initiatives, claims data programs, or credit/rebate model design and implementation
- Experience engaging with PhRMA, industry coalitions, or trade associations on 340B or government pricing policy
- Familiarity with state 340B protection statutes and state drug price transparency reporting requirements
- Experience with the Anti-Kickback Statute, False Claims Act, and healthcare fraud and abuse laws in the context of government pricing and market access
- Excellent oral and written communication skills, including the ability to present complex legal issues clearly and concisely to senior business leaders, executive leadership, and external stakeholders
- Demonstrated ability to manage multiple high-priority matters simultaneously in a fast-paced, matrixed environment
- Strong leadership presence and ability to influence outcomes across functions and at the senior leadership level
- Proven learning agility and ability to adapt legal strategy to a rapidly evolving regulatory and litigation landscape
- Collaborative mindset consistent with Sanofi's values: Aim Higher, Act for Patients, Be Bold, Lead Together
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$206,250.00 - $297,916.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.