We are seeking a Corporate Counsel (or Senior Corporate Counsel, depending on experience) to join the Products/Regulatory Law Group. The position will provide proactive and collaborative regulatory law support for a wide range of internal clients, including marketing, sales, medical, market access, regulatory, and compliance. The position requires a deep understanding of and experience with healthcare laws, including the Food, Drug and Cosmetic Act, the False Claims Act, Anti-Kickback laws, as well as knowledge of market access strategies and patient support programs. The ideal candidate will have in-house experience counseling on an approved product and delivering practical and strategic legal advice on a broad range of issues.
• Provides product support counseling for one or more products/product candidates, from development through commercialization and lifecycle planning:
o Counsels on launch preparation activities for product candidates
o Advises on brand-related strategic planning and business operating plans
o Reviews and approves promotional materials
o Advises on FDA regulatory submissions and labeling negotiations
o Reviews and approves medical materials and publications
o Provides day-to-day client counseling on advertising and promotion, privacy, drug safety, market research, scientific exchange, interactions with healthcare professionals, sponsorships, and grants
• Provides legal advice on market access matters across the product portfolio, including managed care contracting, specialty pharmacy contracting, healthcare coverage and reimbursement issues, patient support programs, government price reporting etc.
• Assists with a broad range of other healthcare regulatory matters including privacy, interactions/contracts with healthcare professionals and patients, patient advocacy, legal counsel to Compliance, reviewing and drafting contracts, and policy development.