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Associate Director, Corporate Counsel - Regulatory And Commercial
Refer job# BIJQ138628
 
Associate Director, Corporate Counsel - Regulatory and Commercial The candidate will provide will provide proactive and collaborative legal support in connection with one or more of firm'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). Provides product support counseling for one or more firm's 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.

The candidate should have JD degree with 5+ years relevant legal experience. Must be 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 is required. Should preferably have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues.
 
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This particular job is currently not active. However, since our clients regularly share with us similar and other job openings, we strongly recommend that you submit your resume. We shall review your resume and get in touch with you as soon as a suitable vacancy comes up to further discuss your interest in exploring the opportunity. Assisting you is our highest priority.

Please be assured that none of your materials will be forwarded to any employer without your consent. Of course, all inquiries are kept strictly confidential.
 
 

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