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Director Market Access Legal Remote

Posted Jun 07
Full Time
RemoteBoston, Massachusetts

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

 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.