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Our client, a publicly-traded biopharmaceutical company in New York, is 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:
Counsels on launch preparation activities for product candidates
Advises on brand-related strategic planning and business operating plans
Reviews and approves promotional materials
Advises on FDA regulatory submissions and labeling negotiations
Reviews and approves medical materials and publications
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.
JD licensed to practice law in New York or be eligible for licensure as a registered in-house counsel
At least 8 plus years relevant legal experience. Prior in-house pharmaceutical and/or biotech experience preferred
Deep knowledge of healthcare laws and life sciences regulatory enforcement trends, including market access/managed care matters. Knowledge of pricing issues is a plus
Exceptional oral and written communication skills, including the ability to communicate clearly and deliver integrated and balanced legal advice
Excellent intrapersonal skills and ability to work in a collaborative, team-oriented environment
Ability to maintain an independent and objective perspective while developing and maintaining strong client relationships
History of self-motivation, meeting aggressive deadlines, and demonstrated success working in high performing and results driven environment
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