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Melinda Burrows
Deputy General Counsel
- Litigation and
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Energy Service Company
LLC
 

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Corporate Counsel
Refer job# RXXN137237
 
Corporate Counsel The candidate will provide legal support to company s Global Product Development (GPD) organization, and other groups responsible for clinical trial quality management and oversight of clinical contract research organization (CRO) and other vendor performance, to ensure minimization of legal risks arising in execution of enterprise level and/or outsourced services for company s global clinical trials. This position will also provide legal support to the Transparency group within company External Medical Affairs (EMA) on matters relating to clinical trial disclosure and data sharing. The role will report to the Assistant General Counsel, Quality, Sponsor Oversight & Operations on the Clinical Development Legal Team which supports company clinical trial activities globally. Provide regulatory compliance advice to clients across the clinical trial organization on matters pertaining to processes and procedures in support of clinical trials, with a particular emphasis on the relationship between sponsors, CROs and vendors. Advise on vendor quality and performance matters, and serve as legal representative on certain vendor governance committees. Provide legal input on selected clinical trial transactional matters, including updates to contract templates used by internal contracting groups in support of clinical trials; and evaluation of clinical trial-related contracts acquired through business acquisitions. Provide legal support on process and contractual matters relating to clinical trial disclosure and data sharing. Provide subject matter expertise, and legal support and guidance, on the development and application of standard operating procedures (SOPs) and related supporting procedural documents for clinical trial support activities. Provide ad hoc legal support on special projects as needed.

The candidate should have excellent academic qualifications including Bachelor's Degree and Juris Doctor. Must be member in good standing of at least one state bar and admitted to practice in relevant jurisdiction. Should have 5 years experience in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry, preferably including some or all of the following: FDA regulatory compliance, Good Clinical Practice (GCP), outsourcing transactions, contract template management. Must have strong interest in, and commitment to, the legal subject matter relevant to this role. Should have excellent research, writing, counselling and communication skills (formal and informal) and a positive client service orientation. Must have accountability, sound judgment, and the ability to take ownership of an issue and provide concise and timely advice.
 
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