Assistant General Counsel

Job title: Assistant General Counsel – 340B

Location: Washington, DC / Morristown, NJ / Cambridge, MA | Travel: Up to 20%

Overview

This senior, high-visibility legal role within Sanofi's LEBI organization focuses on the 340B Drug Pricing Program. The Assistant General Counsel – 340B serves as Sanofi’s primary legal expert and day-to-day counsel on all matters relating to the 340B Integrity Initiative, the 340B Credit Model, and federal and state legal proceedings arising from Sanofi’s efforts to restore transparency and integrity to the program.

Responsibilities

• 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 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 (MDRP, FSS, Medicare PartB), focusing on duplicate discount prevention, Best Price implications, and ceiling price calculations.
• Develop, maintain, and regularly update Sanofi’s legal positions on key 340B interpretive questions, including covered entity eligibility, patient definition, contract pharmacy arrangements, orphan drug exclusions, HRSA oversight, and manufacturer obligations.
• Provide strategic legal counsel to senior leadership on 340B‑related risks, litigation strategy, regulatory developments, and policy options, including preparing and presenting 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.
• Act as Sanofi’s primary legal representative in PhRMA working groups, coalitions, and industry forums focused on 340B reform, government pricing, and market access policy; coordinate Sanofi’s positions with industry peers and advance Sanofi’s legal and policy perspectives.
• Collaborate with Government Affairs and Public Policy teams to develop and advance legislative and regulatory positions on 340B reform at the federal and state levels, engaging with Congress, HHS, HRSA, CMS, and state agencies.
• Engage directly with government and regulatory agencies (HRSA, CMS, HHSOIG, state Medicaid agencies) to educate on policy implications, represent Sanofi’s legal perspective, and advocate for program integrity reforms that reflect 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.

Qualifications

Basic Qualifications

• J.D. from an ABA‑accredited law school; active bar membership in good standing in at least one U.S. jurisdiction.
• Minimum 10years 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 with HHS, HRSA, CMS, DOJ, or state Medicaid agencies, particularly in 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 to senior business leaders 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

• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off (vacation, holidays, sick leave).
• Short‑term and long‑term incentive programs.
• Well‑being and employee support resources.

EEO Statement

Sanofi 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, marital status, gender, gender identity or expression, sexual orientation, disability, veteran or military status, domestic violence victim status, or genetic information.