Life Sciences Attorney (Remote)

We are seeking both experienced Promotional Review lawyers and Market Access lawyers who have at least 5 years of legal practice experience advising clients in the life sciences industry.

Responsibilities

• Serve as legal counsel on promotional review committees, advising on HCP and consumer-facing materials.
• Lead and participate in MLR (Medical, Legal & Regulatory) reviews to ensure promotional content complies with FDA, FTC and other applicable regulations.
• Work closely with cross-functional teams, including marketing, regulatory affairs, and compliance, to develop compliant and effective promotional strategies.
• Assist in the development and delivery of internal policies and training programs related to promotional activities.
• 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.
• 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.
• 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.

Qualifications

• Minimum of 5 years of legal experience with a top law firm, pharmaceutical company, biotech company, CRO or medical device company.
• Strong understanding of regulatory requirements related to product promotional activities and product pricing, fraud and abuse, and Stark and Anti-Kickback issues.
• 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.
• Excellent negotiation, drafting, and communication skills with the ability to convey complex legal concepts to non-legal stakeholders.
• Proactive, solution-oriented mindset with the ability to manage multiple priorities in a fast-paced environment.
• Active admission to practice law in your state of primary residence.

Compensation

The estimated total compensation for full-time Axiom attorney roles is $104,500-325,000 per year and for non-attorney roles is $71,250-309,750 per year. Compensation decisions are based on various factors, including, but not limited to, experience, skills, certifications, location, and business needs. Employees may be eligible for additional benefits, including health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities and tools.