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Job Description
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General Summary:
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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.
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Key Duties and Responsibilities:
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<li> 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.</li>
<li> Provide legal advice and counsel on:
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<li> Market access and reimbursement issues, including contracting with a broad range of customers</li>
<li> Anti-Kickback Statute and other US healthcare compliance laws and regulations</li>
<li> Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act</li>
<li> Government pricing topics, including price reporting compliance policies and reasonable assumptions documents</li>
<li> Centers for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidance</li>
<li> 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</li>
<li> Services and contracting relating to specialty distributors and specialty pharmacies</li>
<li> Data and special projects with our customers</li>
<li> Brand strategic planning and business operation plans</li>
<li> 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</li>
<li> Serves as a member of various cross-functional teams, generally comprising senior company personnel</li>
<li> Participates in various other Legal & Compliance Department projects and initiatives</li>
<li> Collaborate with legal colleagues supporting commercial, pipeline and privacy to ensure delivery of comprehensive legal advice</li>
<li> Review select materials in Communication Review Committee</li>
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Knowledge and Skills:
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<li> Expert knowledge of the laws, regulations and industry standards applicable to the area of responsibility.</li>
<li> Significant understanding of business drivers.</li>
<li> Excellent analytical and complex problem-solving skills, sound judgment.</li>
<li> Outstanding ability to effectively communicate sound legal advice and influence clients, including senior company leaders, to take appropriate actions.</li>
<li> Ability to work cross-functionally and independently.</li>
<li> Ability to work in a fast-paced and dynamic environment.</li>
<li> Ability to drive strategic action.</li>
<li> Ability to create buy-in and trust.</li>
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Education and Experience:
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<li> Qualified lawyer with a JD or LLM</li>
<li> 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</li>
<li> Government price reporting experience</li>
<li> 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</li>
<li> 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</li>
<li> Advanced contracting and redlining skills with strong attention to detail</li>
<li> Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards</li>
<li> Ability to effectively and efficiently manage outside counsel and adhere to a budget</li>
<li> Experience providing legal advice on cell and gene therapies and/or specialty medicines is highly desired</li>
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#LI-Remote
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#LI-AR1
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Company Information
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Vertex is a global biotechnology company that invests in scientific innovation.
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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.
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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.
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Posted
Updated
Practice Areas
Health Care
Specialties
Compliance/Regulatory, False Claims Act, Medicaid, Medicare, Pharmaceuticals, Stark