Corporate Counsel, Clinical/Regulatory Counsel Jobs in New_York - 156418 | Submit Resume | General Counsel Consulting
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Corporate Counsel, Clinical/Regulatory
Refer job# UFGE156418
 
Corporate Counsel, Clinical/Regulatory Responsibilities: Serve as a business partner to and support the Clinical Development and Regulatory organizations, including the clinical operations, quality and CMC teams. Advise clients on business transactions and apply knowledge of laws and regulations. Draft and negotiate corporate and commercial agreements, including clinical trial site agreements, CRO agreements, manufacturing and other supply chain agreements, licensing agreements and MSAs. Support all aspects of clinical trial start up and continuation, in the United States and ex-U.S. Prepare guidance and training materials to support the efficient and compliant negotiation of clinical research-related agreements. Serve as a point of contact for internal and external contract negotiations and work collaboratively with business and legal colleagues to develop pragmatic, creative and compliant solutions. Other duties and projects as assigned.

Requirements: JD Degree from an accredited, top-tier law school. 7-12 years of prior legal experience. Admission to a state bar association in the United States. Knowledge of current laws, regulations and industry standards governing clinical trials, such as FDA regulations, ICH Guidelines and GCPs. Significant experience drafting and negotiating corporate and commercial agreements, including clinical trial site agreements, CRO agreements, manufacturing and other supply chain agreements and licensing agreements. Strong legal, communication, customer service and negotiation skills. High degree of personal ethics, integrity and accountability. Proven ability and interest in working across a broad range of subject matter areas and succeeding in the fast-paced environment of a biotechnology company. Capable of appropriately triaging workflow, setting clear priorities and expectations with clients and external parties, and efficiently delivering results in a pragmatic and risk-balanced manner. Demonstrated ability to identify potential legal issues and propose solutions to address business requirements while appropriately mitigating risk. Team player with the ability to develop and maintain strong business relationships across the company and contribute to cross-functional and departmental projects. Prior professional experience in-house at a life sciences or pharmaceutical company, government agency or healthcare institution working on healthcare and clinical trial related matters is preferred.
 
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