Assistant General Counsel 340B

Job title: Assistant General Counsel 340B Location: Washington, DC / Morristown, NJ / Cambridge, MA Travel: Up to 20% This is a senior, high‑visibility legal role within Sanofi's LEBI organization. The Assistant General Counsel 340B will serve as Sanofi's primary legal expert and day‑to‑day counsel on all matters relating to the 340B Drug Pricing Program, including Sanofi's 340B Integrity Initiative, the 340B Credit Model, and the full spectrum of federal and state legal proceedings arising from Sanofi's efforts to restore transparency and integrity to the 340B program. Sanofi has been a leading voice in the pharmaceutical industry's effort to address well‑documented abuses of the 340B program, including illegal diversion and duplicate discounts that undermine the program's original mission of delivering affordable care to vulnerable patients. This role will be central to managing and advancing all legal aspects related to that mission. This position offers a rare opportunity to shape industry‑defining legal strategy at a company that has been at the absolute forefront of 340B reform working alongside exceptional colleagues in a company that values bold thinking, unwavering integrity, and a relentless focus on patients. Sanofi is an R&D-driven, AI‑powered biopharma company guided by one purpose: we chase the miracles of science to improve people's lives. We are committed to improving people's lives and delivering compelling growth through innovative medicines and vaccines that address unmet clinical needs and transform the standard of care. Our Legal, Ethics & Business Integrity (LEBI) team composed of lawyers, patent attorneys, compliance officers, and security professionals plays an essential role in protecting the interests of the company's business, patients, shareholders, and employees while delivering on Sanofi's strategy and contributing to its long‑term ambition to transform the practice of medicine. Responsibilities 340B Integrity Initiative, Credit Model & Associated Legal Proceedings 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 HRSA Administrative Dispute Resolution (ADR) proceedings. Monitor, analyze, and advise on federal and state 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. Basic Qualifications J.D. from an ABA‑accredited law school; active bar membership in good standing in at least one U.S. jurisdiction. Minimum 10 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. Benefits Sanofi offers a comprehensive benefits package to eligible employees, including medical, dental, and vision insurance; 401(k) with company match; paid time off (vacation, holidays, sick leave); short‑and long‑term incentive programs; and a range of well‑being and employee support resources. Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks gender‑neutral parental leave. 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. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. #J-18808-Ljbffr BioSpace