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Associate Director, Corporate Counsel Regulatory & Commercial Law
Refer job# SEBH144467
 
Associate Director, Corporate Counsel Regulatory & Commercial Law Requisition Number: 16919BR The candidate will provide proactive and collaborative legal support in connection with one or more products as well as legal advice to a wide range of internal clients, including sales, marketing, 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 the discovery, development, 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. Provide product support counseling in connection with one or more products/product candidates from development through commercialization and lifecycle planning. Review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Will serve as voting legal member on relevant external funding committees and proactively help to develop and improve necessary policies and procedures. Review and approve needs assessments in connection with proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Provide legal support as needed on patient assistance programs and market access contracts. Assist with a broad range of other healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development.

The candidate should have JD with 5+ years relevant legal experience. Should be Licensed to practice law in New York or 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. Should have exceptional oral and written communication skills, including drafting skills, and presentation capabilities. Should have excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment. Should have ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations.
 
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