Remotery

Market Access Lawyer – Pharmaceutical Industry

atAxiomUS flagCaliforniaFull-timeUncategorizedMid-levelSenior$104.5k – $325k/year

Posted 4 hours ago

This is a fully remote position, open to applicants in California.

📋 Description

• Drafting, reviewing, negotiating, and providing counsel on a wide array of market access-related agreements, such as PBM, payer, GPO, wholesaler, specialty pharmacy, distribution, rebate, discount, value-based, outcomes-based, consulting, advisory board, master services, and data-sharing agreements.

• Offering legal advice 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 collaboration with market access, health economics and outcomes research (HEOR), pricing, trade, and channel teams.

• Providing guidance to clients on the design, implementation, and management of patient support programs, co-pay assistance programs, and related arrangements, with a specific focus on considerations under the Anti-Kickback Statute and False Claims Act.

• Working alongside commercial, medical, regulatory, compliance, finance, and market access teams to ensure that access-related strategies, communications, and materials adhere to relevant laws, regulations, and industry standards.

• Overseeing legal and compliance matters related to pharmaceutical pricing, reimbursement, government reporting, and payer contracting activities.

• Delivering practical, risk-based advice concerning interactions with payers, pharmacy benefit managers (PBMs), healthcare professionals, and government healthcare programs.

• Keeping abreast of federal and state regulatory changes, enforcement trends, and industry guidance affecting 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 within a pharmaceutical, biotechnology, or biopharmaceutical company.

• Strong understanding of laws, regulations, and guidance that govern 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 experience in drafting and negotiating PBM, payer, GPO, wholesaler, rebate, and other market access-related agreements.

• Experience in advising on advertising and promotion, scientific exchange, patient support programs, and interactions with healthcare professionals and payers.

• Demonstrated capability to translate complex regulatory requirements into practical, business-oriented, and risk-based strategies.

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


🏝️ Benefits

• Health, dental, and vision insurance.

• Paid holidays and PTO.

• Flexible work arrangements.

• Professional development opportunities and tools.

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