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 company integrity and reputation.
- Provide legal advice and counsel on Medicaid, Medicare, 340B, and Veterans Health Care Act obligations.
- Advise on market access and reimbursement.
- Advise on government pricing (price reporting compliance policies; reasonable assumptions documents).
- Advise on CMS final rules/correspondence, including letters and public comments.
- Advise on proposed/enacted federal and state legislation affecting market access and pricing transparency.
- Advise on services and contracting for specialty distributors and specialty pharmacies.
- Support data and special projects; brand strategic planning and business operation plans.
- Stay current on healthcare legislation/regulations and enforcement.
- Ensure compliance with applicable laws and company policies, including Anti-kickback Statute and related healthcare compliance laws.
- Collaborate with legal teams (commercial, pipeline, privacy); review select materials in the Communication Review Committee.
Qualifications / Skills
- JD from an ABA-accredited law school; member of a state bar.
- 8+ years post-JD advising in life sciences (law firm and/or in-house in biopharma).
- Government price reporting experience.
- Experience advising on Medicaid/340B/Veterans Administration, anti-kickback statutes, state drug pricing transparency laws, OIG guidance/advisory opinions, False Claims Act, and PhRMA Code.
- Strong verbal/written communication; ability to advise lawyers and non-lawyers.
- Advanced contracting and redlining skills; high attention to detail.
- Excellent analytical/problem-solving/organizational skills; manage multiple priorities.
- Ability to manage outside counsel and adhere to budget.
- Specialty medicines legal experience highly desired.