Life Sciences Attorney

🔥 8 minutes ago

🇺🇸 United States – Remote

💵 $104.5k - $325k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧑‍💼 Attorney / Lawyer

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Axiom

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2000

⚖️ Legal

☁️ SaaS

🤝 B2B

Legal • SaaS • B2B

Axiom is a company that provides legal services and law-related technology, simplifying the process of managing legal accounts for users. Their focus on accessibility and user-friendly processes highlights their commitment to modernizing the legal experience.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• health, dental, and vision insurance • paid holidays and PTO • flexible work arrangements • professional development opportunities and tools