Overview
The organization is seeking experienced Promotional Review lawyers and Market Access lawyers with a minimum of 5 years of legal practice experience advising clients in the life sciences industry.
Responsibilities
- Serve as legal counsel on promotional review committees, advising on healthcare professional (HCP) and consumer-facing materials.
- Lead and participate in Medical, Legal & Regulatory (MLR) reviews to ensure promotional content complies with FDA, FTC, and other applicable regulations.
- Collaborate with cross-functional teams including marketing, regulatory affairs, and compliance to develop compliant and effective promotional strategies.
- Assist in developing and delivering internal policies and training programs related to promotional activities.
- Draft, review, negotiate, and advise on a broad range 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.
- Work 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.
- Provide 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
- At least 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, product pricing, fraud and abuse, and Stark and Anti-Kickback issues.
- In-depth 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 explain complex legal concepts to non-legal stakeholders.
- Proactive and solution-oriented mindset with the ability to manage multiple priorities in a fast-paced environment.
- Active admission to practice law in the state of primary residence.
Compensation & Benefits
- Estimated total compensation for full-time attorney roles ranges from $104,500 to $325,000 per year.
- Estimated total compensation for non-attorney roles ranges from $71,250 to $309,750 per year.
- Compensation decisions are based on factors including experience, skills, certifications, location, and business needs.
- Eligible employees may receive benefits such as health, dental, and vision insurance; paid holidays and paid time off; flexible work arrangements; and professional development opportunities and tools.
Location
This role covers North America, the UK, Europe, and APAC regions. Candidates must have active admission to practice law in their state of primary residence.