Job Summary
Provide expert legal advice and counseling to business partners on strategic and tactical projects in a highly regulated environment. Report to the Assistant General Counsel and support departments including Market Access (Payer Strategy, Trade & Distribution, Government Pricing), Government Affairs & Public Policy, and pipeline.
Key Responsibilities
Provide legal advice and counsel to advance commercial initiatives while managing legal risk and protecting company integrity and reputation, including:
- Medicaid, Medicare, 340B program, and Veterans Health Care Act statutory/regulatory obligations
- Market access and reimbursement issues
- Government pricing and price reporting compliance (including reasonable assumptions documents)
- Centers for Medicare & Medicaid final rules and correspondence (letters and public comments)
- Federal and state legislation affecting market access, pricing, and reimbursement, including state drug price reporting/transparency laws
- Services and contracting for specialty distributors and specialty pharmacies
- Data and special projects; brand strategic planning and business operation plans
- Stay abreast of healthcare legislation/regulations and enforcement landscape
- Ensure compliance with Anti-kickback Statute and other US healthcare compliance laws
- Collaborate with colleagues supporting commercial, pipeline, and privacy
- Review select materials in Communication Review Committee
Contribute to Legal & Compliance Department
- Participate in legal/compliance initiatives and committees (e.g., Culture, Pro Bono & Community Engagement)
- Share information through presentations and discussions
Qualifications (Required/Preferred)
- JD from an ABA-accredited law school; member of a state bar
- 8+ years post-JD advising in life sciences (law firm or in-house)
- Government price reporting experience
- Experience advising on market access statutes/regulations/guidance (Medicaid, 340B, Veterans Administration, federal/state anti-kickback statutes, state drug pricing transparency laws, OIG guidance/advisory opinions, False Claims Act, PhRMA Code)
- Advanced contracting/redlining skills; strong analytical, problem-solving, and organizational skills; manage outside counsel/budget
- Strong communication skills; sound advice for lawyers and non-lawyers
- Specialty medicines legal experience highly desired