Life Sciences Attorney

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

📋 Description

• Act as legal advisor on promotional review committees, providing guidance on materials aimed at healthcare professionals (HCP) and consumers.

• Lead and engage in MLR (Medical, Legal & Regulatory) evaluations to confirm that promotional content adheres to FDA, FTC, and other relevant regulations.

• Collaborate closely with cross-functional teams, such as marketing, regulatory affairs, and compliance, to create compliant and effective promotional strategies.

• Support the creation and implementation of internal policies and training programs related to promotional activities.

• Draft, review, negotiate, and provide counsel on a variety of market access agreements, including those related to PBM, payer, GPO, wholesaler, specialty pharmacy, distribution, rebate, discount, value-based, outcomes-based, consulting, advisory board, master services, and data-sharing.

• Work in partnership with commercial, medical, regulatory, compliance, finance, and market access teams to ensure that access-related strategies, communications, and materials are in compliance with applicable laws, regulations, and industry standards.

• Offer legal insight 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.

⛳️ Requirements

• At least 5 years of legal experience with a prominent law firm, pharmaceutical company, biotech firm, CRO, or medical device company.

• Strong grasp of regulatory requirements pertinent to product promotional activities, pricing, fraud and abuse, as well as Stark and Anti-Kickback matters.

• Comprehensive knowledge of laws, regulations, and guidelines governing pharmaceutical commercial and market access endeavors, 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.

• Exceptional negotiation, drafting, and communication abilities, with the skill to articulate complex legal concepts to non-legal audiences.

• Proactive, solution-focused mentality with the capacity to juggle multiple priorities in a fast-paced environment.

• Active license to practice law in your state of primary residence.

🏝️ Benefits

• Health, dental, and vision insurance

• Paid holidays and PTO

• Flexible work arrangements

• Professional development opportunities and tools