Role Summary
Legal Senior Counsel, Market Access role within a US-based remote Legal & Compliance Department. Provides expert advice and counseling on market access, government pricing, and policy topics to business partners across Market Access, Trade & Distribution, Government Pricing, Government Affairs & Public Policy, and clinical pipeline support. Requires experience counseling prescription drug companies on market access, pricing, contracting, and related regulations.
Responsibilities
- Advise business partners on commercial initiatives, balancing strategic goals with legal risk and integrity.
- Provide legal counsel on market access and reimbursement, contracting with customers in distribution, and US healthcare compliance laws and regulations (e.g., Anti-Kickback Statute).
- Address statutory and regulatory obligations under Medicaid, Medicare, 340B, Veterans Health Care Act.
- Handle government pricing topics, including price reporting policies and related documents.
- Review CMS final rules, correspondence, public comments on proposed rules and guidance; monitor federal/state legislation affecting market access, pricing, and transparency.
- Support services and contracting with specialty distributors/pharmacies; assist with data projects and customer-facing initiatives.
- Contribute to brand strategic planning and business operation plans; stay updated on healthcare legislation and enforcement trends.
- Collaborate with legal colleagues across commercial, pipeline, and privacy to deliver comprehensive advice; review internal/external materials as needed.
Qualifications
- JD from an ABA-accredited law school; member of a state bar.
- Minimum 8 years post-JD experience in life sciences legal matters (law firm, in-house, or both).
- At least 3 years in a fast-paced environment; experience advising on market access statutes/regulations (including anti-kickback, Medicaid/340B/Veterans programs, state drug pricing transparency, OIG guidance, False Claims Act).
- Strong written and verbal communication; ability to translate legal concepts for non-lawyers; business-oriented mindset.
- Advanced contracting and redlining skills; meticulous attention to detail; strong analytical and organizational abilities.
- Experience managing outside counsel and budgets; experience with cell/gene therapies or specialty medicines is highly desirable.
Skills
- Legal advisory skills for market access, government pricing, and policy; contracting and compliance.
- Strategic thinking with ability to balance legal risk and business goals.
- Excellent communication, negotiation, and problem-solving abilities.
- Ability to manage multiple priorities and collaborate cross-functionally.
Education
- Juris Doctor (JD) from an ABA-accredited law school