Job Summary
Provide expert legal advice and counseling to the business on strategic and tactical projects in a highly regulated environment. Report to the Assistant General Counsel and support business partners across Market Access (Payer Strategy, Trade & Distribution, Government Pricing), Government Affairs & Public Policy, and pipeline.
Key Responsibilities
- Advise business partners on commercial initiatives to advance strategy while addressing legal risks and protecting integrity/reputation.
- Provide legal counsel on:
- Statutory/regulatory obligations under Medicaid, Medicare, 340B program, and Veterans Health Care Act
- Market access and reimbursement issues
- Government pricing (price reporting compliance policies; reasonable assumptions documents)
- Centers for Medicare and Medicaid final rules; correspondence (letters/public comments on proposed rules/guidance)
- Federal and state legislation impacting pharmaceutical market access/pricing/reimbursement and state drug price reporting/transparency compliance
- Services and contracting for specialty distributors and specialty pharmacies
- Data and special projects
- Brand strategic planning and business operation plans
- Evolving healthcare legislation/regulations and enforcement landscape
- Compliance with applicable laws and company policies, including the Anti-kickback Statute and other US healthcare compliance laws/regulations
- Collaborate with legal colleagues (commercial, pipeline, privacy) to deliver comprehensive advice
- Review select materials in the Communication Review Committee
- Contribute to Legal & Compliance Department projects/initiatives and committees; share knowledge via presentations/discussions.
Qualifications / Preferred Experience
- JD from an ABA-accredited law school
- Member of a state bar
- 8+ years post-JD experience advising on legal matters in a life sciences space (law firm and/or in-house)
- Government price reporting experience
- Experience advising on market access statutes/regulations/guidance, including Medicaid, 340B, VA, federal/state anti-kickback statutes, state drug pricing transparency laws, OIG guidance/advisory opinions, False Claims Act, and PhRMA Code
- Strong communication (verbal/written) and ability to give sound advice to lawyers and non-lawyers
- Advanced contracting and redlining skills; attention to detail
- Strong analytical/problem-solving/organizational skills; ability to handle multiple priorities timely
- Ability to manage outside counsel and adhere to budget
- Experience providing legal advice on specialty medicines (highly desired)