Job Summary
Provide expert advice and counseling to the business on strategic and tactical projects in a highly regulated environment. Report to the Assistant General Counsel and provide legal support to 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 company strategy while addressing legal risks and protecting company integrity and reputation.
- Provide legal advice and counsel on:
- Medicaid, Medicare, 340B program, Veterans Health Care Act statutory/regulatory obligations
- Market access and reimbursement
- Government pricing and price reporting compliance policies/reasonable assumptions documents
- Centers for Medicare & Medicaid final rules and correspondence (letters and public comments)
- Proposed/enacted federal and state legislation impacting market access, pricing, 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
- Evolving healthcare legislation/regulations and enforcement landscape
- Compliance with applicable laws/company policies, including Anti-kickback Statute and other US healthcare compliance laws
- Coordinate with colleagues (commercial, pipeline, privacy) to deliver comprehensive legal advice
- Review select materials in Communication Review Committee
- Contribute to Legal & Compliance Department projects/initiatives; share knowledge via group presentations and discussions.
Qualifications/Skills
- JD from an ABA-accredited law school; member of a state bar.
- 8+ years post-JD experience advising on legal matters in life sciences (law firm and/or in-house).
- Government price reporting experience.
- Knowledge of statutes/regulations/guidance for market access (Medicaid, 340B, Veterans Administration), federal/state anti-kickback statutes, state drug pricing transparency laws, OIG guidance/advisory opinions, False Claims Act, and PhRMA Code.
- Strong verbal/written communication to counsel lawyers and non-lawyers; strong business understanding.
- Advanced contracting and redlining skills; strong attention to detail.
- Excellent analytical, problem-solving, and organizational skills; ability to manage multiple responsibilities.
- Ability to manage outside counsel and adhere to budget.
- Experience advising on specialty medicines highly desired.