Company: Vertex Pharmaceuticals
Industry: Private
Employment Type: Full-time
Working Hours: 8 Hours
Job Location: USA
Full 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