Director Market Access Legal

1 month ago

Boston, United States Vertex Pharmaceuticals Full time

Job Description

General Summary:

The Legal Senior Counsel provides solutions-oriented legal advice and support to assigned business functions on a broad array of strategic and tactical matters within a highly regulated environment. The Legal Senior Counsel demonstrates a high degree of autonomy representing significant risk and complexity, working closely with senior company leaders.

Key Duties and Responsibilities:

  • Advise internal clients on legal matters in a way that advances the company's strategy while addressing legal risks and protecting the company's integrity and reputation.
  • Provide legal advice and counsel on:
    • Market access and reimbursement issues, including contracting with a broad range of customers.
    • Anti-Kickback Statute and other US healthcare compliance laws and regulations.
    • Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act.
    • Government pricing topics, including price reporting compliance policies and reasonable assumptions documents.
    • Centers for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidance.
    • Proposed and enacted United States federal and state legislation impacting pharmaceutical companies relating to market access, pricing, reimbursement as well as state drug price reporting and transparency laws and compliance.
    • Services and contracting relating to specialty distributors and specialty pharmacies.
    • Data and special projects with our customers.
    • Brand strategic planning and business operation plans.
    • Subject matter expert on matters within the area of accountability, staying abreast of evolving regulations and the enforcement landscape, analyzing trends and communicating effectively within the organization.
    • Serves as a member of various cross-functional teams, generally comprising senior company personnel.
    • Participates in various other Legal & Compliance Department projects and initiatives.
    • Collaborate with legal colleagues supporting commercial, pipeline and privacy to ensure delivery of comprehensive legal advice.
    • Review select materials in Communication Review Committee.

Knowledge and Skills:

  • Expert knowledge of the laws, regulations and industry standards applicable to the area of responsibility.
  • Significant understanding of business drivers.
  • Excellent analytical and complex problem-solving skills, sound judgment.
  • Outstanding ability to effectively communicate sound legal advice and influence clients, including senior company leaders, to take appropriate actions.
  • Ability to work cross-functionally and independently.
  • Ability to work in a fast-paced and dynamic environment.
  • Ability to drive strategic action.
  • Ability to create buy-in and trust.

Education and Experience:

  • Qualified lawyer with a JD or LLM.
  • Minimum of 8 years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry, or both.
  • Government price reporting experience.
  • Experience advising on statutes, regulations, and guidance documents applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance documents and advisory opinions, the False Claims Act, and the PhRMA Code.
  • Outstanding ability to effectively communicate (verbally and in writing), sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs.
  • Advanced contracting and redlining skills with strong attention to detail.
  • Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards.
  • Ability to effectively and efficiently manage outside counsel and adhere to a budget.
  • Experience providing legal advice on cell and gene therapies and/or specialty medicines is highly desired.
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