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Our client, a publicly-traded biopharmaceutical company is New York, is seeking a Corporate Counsel to join the Regulatory and Commercial Law Group. The position will provide proactive and collaborative legal support in connection with one or more of the company’s products and legal advice to a wide range of internal clients, including sales, commercial, medical affairs, regulatory, and compliance. The level of counseling requires a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to discovery, development and sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing 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 and strategies,
Advises on FDA regulatory submissions and label negotiations,
Reviews and approves medical materials and publications,
Provides day-to-day counseling on advertising and promotion, drug safety, scientific exchange, strategic commercial activities, interactions with healthcare professionals, and external funding activities.
Trains and educates clients on enforcement trends and discrete legal issues.
Has proven ability to influence clients by identifying and communicating relevant legal risks and understanding the impact that decisions may have on business activities.
Provides counsel and support to Compliance, including supporting policy development and providing training to commercial, medical, sales and other departments.
Assists with a broad range of other healthcare regulatory matters including monitoring the enforcement environment, client training, compliance monitoring and investigations, market access, patient advocacy, contracts, patient assistance programs, and policy development.
Qualifications: • JD with at least 5+ years relevant legal experience • Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. • Prior in-house healthcare/pharmaceutical and/or biotech experience strongly preferred. • Significant knowledge of life sciences regulatory enforcement trends, the FDCA, the false claims act, and fraud and abuse laws • Excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment.
Essential Skills and Abilities: • Exceptional oral and written communication skills, including drafting skills, and presentation capabilities. • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations. • History of self-motivation, working independently on projects, meeting aggressive deadlines, and juggling multiple matters. • Market access counseling experience a plus.
Internal Number: CORP 1085
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