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
Requirements
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
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
Juris Doctor (JD) degree or equivalent and active license to practice law in at least one U.S. jurisdiction.