Director Market Access Legal

Vertex Pharmaceuticals

Location
Massachusetts-Boston
Description
<div id="jobDescriptionText" class="jobsearch-JobComponent-description css-16y4thd eu4oa1w0"><div> <div> Job Description </div> <div> General Summary: </div> <div> 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. </div> <div></div> <div> Key Duties and Responsibilities: </div> <ul> <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: <ul> <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 &amp; 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> </ul></li> </ul> <div></div> <div> Knowledge and Skills: </div> <ul> <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> </ul> <div></div> <div> Education and Experience: </div> <ul> <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> </ul> <div></div> <div> #LI-Remote </div> <div> #LI-AR1 </div> <div></div> <div> Company Information </div> <div> <div> Vertex is a global biotechnology company that invests in scientific innovation. </div> <div></div> <div> 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. </div> <div></div> <div> 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. </div> </div> </div></div>
Posted
Updated
Practice Areas
Health Care
Specialties
Compliance/Regulatory, False Claims Act, Medicaid, Medicare, Pharmaceuticals, Stark
Experience
8+ years
Employer Type
In-House