Sr. Manager / Associate Director, Clinical Documentation

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POST DATE 8/27/2016
END DATE 10/26/2016

Regeneron Pharmaceuticals, Inc. Tarrytown, NY

Company
Regeneron Pharmaceuticals, Inc.
Job Classification
Full Time
Company Ref #
360445
AJE Ref #
575993120
Location
Tarrytown, NY
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. br / br / Summary: br / The Senior Manager, Clinical Documentation, provides direction and support to Clinical Study Teams (CST) on Regeneron and vendor clinical document management standards and practices. br / The Senior Manager also provides direction and support to the Clinical Logistics documentation coordination team for clinical document review, Trial Master File (TMF) archiving and clinical file room activities. The Senior Manager is a subject matter expert on essential documents, ICH guidelines and GCPs, and will develop SOPs, work instructions, and the tools necessary to ensure compliance with clinical trials regulations and Regeneron records retention policies. br / br / Responsibilities: br / br / TMF Support /p ul dir="ltr" li Lead and oversee TMF support for clinical trials. Includes submission and audit preparation, troubleshooting, supporting business needs. /li li Effectively communicate and drive document management compliance and quality issues to the clinical study teams and management, and offer potential solutions. /li li Support the clinical study teams in ensuring regulatory documents are submission and audit ready /li li Assist with vendor TMF review and site visits, as applicable. /li li Function as subject matter expert on local and international GCPs related to TMF. /li /ul p Process Development and Standards /p ul dir="ltr" li Develop and implement standards for document workflow, organization and maintenance of documents in the Clinical File Room and external archives. /li li Develop and implement record retention policies for clinical documentation in accord with Corporate, Legal and CDRA policies. /li li Develop and contribute to the implementation plan for an electronic TMF, including standards, governance and charter. /li /ul p Training /p ul dir="ltr" li Develop, assess, and provide training for TMF-related SOPs, working practices, and forms, as needed, in order to ensure adequate compliance. /li /ul p Reporting /p ul dir="ltr" li Provide status updates and information to Senior Director Clinical Operations and other Clinical management on a regular basis. /li /ul p Supervisory /p ul dir="ltr" li May supervise and/or manage day-to-day activities of staff, e.g., Clinical Documentation Associates /li /ul p /p p Requirements: /p