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Senior Corporate Counsel/senior Director Research & Development Compliance
Refer job# SORI136303
 
Senior Corporate Counsel/Senior Director Research and Development Compliance The candidate will be responsible for overseeing the execution of company s Compliance program for R&D colleagues globally. Will support enterprise R&D initiatives and serve as the primary compliance advisor to the company Essential R&D organization. The R&D Compliance Director/Counsel will have regular communication and coordination with attorneys in the Clinical Development, Business Transactions, Regulatory and Law groups, as well as with colleagues in GRCC, WRD Operations, and Medical Quality Assurance. The position will report to the Global Compliance Lead for Research & Development. Oversee and execute company s Compliance program for PEH R&D colleagues globally. Manage and engage in proactive worldwide compliance activities for PEH R&D colleagues including: (i) identification, assessment and mitigation of risk; (ii) training and outreach efforts, and (iii) development of tools and controls to drive compliance and enhance a culture of integrity. Coordinate compliance-related communications, including updates to PEH R&D leadership on external enforcement environment activity and other compliance-related issues of importance, including investigations trends involving PEH R&D colleagues. Provide subject matter expertise, advice and counsel to colleagues in R&D functions across the organization, as needed, on healthcare law and other compliance topics including HCP engagement, GPIHP, transparency laws, FCPA compliance, conflicts of interest, and non-clinical publications and support the management of related SOPs and guidance documents. Oversee proactive reviews and special projects designed to identify and mitigate compliance risks involving the R&D organization. Provide compliance support for the Worldwide 5Research & Development and Global Product Development (GPD) Compliance Committees, including support for dashboard development and metrics collection. Provide support for integration activities that impact PEH R&D and other enterprise R&D functions/colleagues An Excellent academic qualifications, including bachelor s degree, required. Advanced academic qualification/degree (such as Juris Doctor) is preferred. Must have proven capabilities including 10+ years of experience in some or all of the following areas: healthcare compliance, healthcare law and policy, regulatory law, FCPA or other commercial legal or transactions practice.
 
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