Market Access Lawyer - Pharmaceutical Industry

Responsibilities:

• Drafting, reviewing, negotiating, and advising on a broad range of market access-related agreements, including PBM, payer, GPO, wholesaler, specialty pharmacy, distribution, rebate, discount, value-based, outcomes-based, consulting, advisory board, master services, and data-sharing agreements.
• Providing legal guidance on market access, pricing, reimbursement, and government pricing obligations, including Medicaid Best Price, Average Manufacturer Price (AMP), Average Sales Price (ASP), 340B, and VA/FSS requirements.
• Advising on coverage, coding, and reimbursement initiatives in partnership with market access, health economics and outcomes research (HEOR), pricing, trade, and channel teams.
• Counseling clients on the design, implementation, and operation of patient support programs, co-pay assistance programs, and related arrangements, with particular focus on Anti-Kickback Statute and False Claims Act considerations.
• Collaborating with commercial, medical, regulatory, compliance, finance, and market access teams to ensure access-related strategies, communications, and materials comply with applicable laws, regulations, and industry standards.
• Managing legal and compliance issues related to pharmaceutical pricing, reimbursement, government reporting, and payer contracting activities.
• Providing practical, risk-based advice regarding interactions with payers, pharmacy benefit managers (PBMs), healthcare professionals, and government healthcare programs.
• Staying ahead of federal and state regulatory developments, enforcement trends, and industry guidance impacting market access, pricing, reimbursement, and commercial contracting.

Qualifications:

• 5–8 years of experience as an attorney in a law firm and/or in-house legal department with a pharmaceutical, biotechnology, or biopharmaceutical company, with significant experience supporting market access, pricing, reimbursement, and/or government pricing matters.
• Strong knowledge of laws, regulations, and guidance governing pharmaceutical commercial and market access activities, including FDA regulations, the Federal Food, Drug, and Cosmetic Act (FDCA), federal and state Anti-Kickback Statutes, beneficiary inducement rules, OIG guidance and advisory opinions, the False Claims Act, and the PhRMA Code.
• Proven track record drafting and negotiating PBM, payer, GPO, wholesaler, rebate, and other market access-related agreements.
• Experience advising on advertising and promotion, scientific exchange, patient support programs, and interactions with healthcare professionals and payers.
• Demonstrated ability to translate complex regulatory requirements into practical, business-oriented, and risk-based strategies.
• Excellent communication, negotiation, technology, and problem-solving skills, with the ability to work independently and collaborate effectively across cross-functional teams.
• Juris Doctor (JD) degree or equivalent and active license to practice law in at least one U.S. jurisdiction.