Assistant General Counsel, US Market Access Legal

Job Title: Assistant General Counsel, US Market Access Legal

Location: Washington DC, Cambridge, MA, Morristown, NJ

About the Job

Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

This role is responsible for providing strategic legal guidance on pricing, reimbursement, and market access for pharmaceutical and vaccines products in the U.S. The position involves collaboration with various departments including Market Access and Government Affairs to ensure compliance with laws and regulations while supporting the company's mission to make healthcare more affordable and accessible. This role will identify, develop, and execute key Legal strategies to advance company priorities with a significant focus on the dynamic 340B pricing space and related legal, regulatory, and policy issues.

This position reports to the Head of Market Access, Legal and is based in either Washington, DC, Cambridge, MA, or Morristown, NJ.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Government Pricing & Compliance

• Serve as lead counsel for Government Pricing, advising on compliance with government price reporting laws and state drug price transparency requirements

• Draft reasonable assumption documentation, policies, and procedures related to pricing

• Provide guidance on the Inflation Reduction Act ("IRA") and other federal laws affecting pharmaceutical pricing

• Advise on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements

• Draft correspondence to Centers for Medicare and Medicaid ("CMS") including letters and public comments on proposed rules and guidance

• Develop price reporting compliance policies and advise on related internal training and audits

340B Program Leadership

• Advise business teams on key day-to-day 340B compliance and program integrity issues

• Support the development and implementation of strategies to ensure compliance with 340B program requirements

• Navigate disputes and audits related to the 340B program

• Serve as lead internal Legal resource on key industry market access policy issues

Strategic & Business Support

• Support Government Affairs by analyzing prospective laws and developing lobbying strategies

• Engage with government and regulatory agencies to educate on specific policies and laws

• Provide strategic Legal counsel on reimbursement and access matters

• Develop strategies to navigate and/or shape the external environment and advance company objectives

• Determine prioritization, timeline, and resourcing needs for strategic initiatives and gain internal alignment

• Drive cross-functional team execution and progress

General Legal Support

• Manage outside counsel providing services in support of this role

• Conduct training for management and employees on emerging Legal topics

About You

Requirements

Education & Experience

• Juris Doctor (JD) degree from a highly respected, accredited law school

• Minimum 12 years of prior experience at a law firm and/or in-house legal department

• Licensed to practice law and in good standing in at least one US jurisdiction (DC, MA or NJ preferred)

• Pharmaceutical industry experience, either in-house or through private practice

Technical Knowledge

• Strong proficiency in government price reporting including AMP, ASP, Best Price, Federal Supply Schedule, and 340B

• Extensive knowledge of government healthcare programs (Medicaid, Medicare, Tricare, VA)

• Deep understanding of healthcare-related laws including Anti-Kickback Statute and False Claims Act

• Experience with competition, pricing, reimbursement, and access issues in the pharmaceutical industry

• Working knowledge of US Federal and state healthcare compliance considerations

Professional Skills

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