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Corporate Counsel, Clinical Development
Refer job# ZKNR137571
 
Corporate Counsel, Clinical Development The candidate will be involved in all aspects of the development business and operate as part of cross-functional teams focused on developing pipeline products in the U.S. and acquiring or licensing products in the U.S. Will be responsible for evaluating strategic and tactical research and development and business development plans, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP requirements, product development, product labeling, non-promotional review, media materials, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy, medical, industry and group company issues. Provides strategic advice regarding research and development projects, business development matters, regulatory matters, compliance issues, contracts and interactions with respect to pipeline pharmaceuticals. Provides advice regarding research and development, business development, product sourcing and development, and competition practices. Performs drafting and negotiation of contracts for the local business and advises management in connection with related matters. Partners with legal department colleagues at MCHA in New York City and Jersey City in executing and enhancing Company and Legal Department objectives. Supervises outside counsel as required. Drives increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the local business. Emphasizes effective demand management, providing innovative solutions to meet client needs and address highest risks. Works as part of a matrix leadership team at MTDA and MTHA (handling matters including clinical, regulatory, safety, medical, sourcing, finance, and HR). Assists with supporting compliance function; helps create and deliver policies, procedures and training to MTDA and MTHA teams. Leads by example and ensures consistent communication to MTDA and MTHA; is a beacon of compliance as a representative of the MCHA compliance program. Should have JD degree. Must be admitted to the Bar of at least one state; and eligible for admission to the New York and New Jersey Bar (in-house counsel license acceptable). Should preferably have 4+ years of experience handling transactions for a major law firm complemented by another 4 or more years of in-house experience with clinical development work. Experience with FDA regulations and guidance provided by the Office of the Inspector General for HHS is required.
 
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