Senior Associate, TMF Management

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Senior Associate, TMF Management sought in Nutley, NJ. Perform global management activities relating to electronic Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. Maintain and set up eTMF system, create and manage TMF Plan and filing expectations; eTMF Quality Issue resolution, eTMF user support, and assist with the oversight of the eTMF vendor; initiate quality control reviews of eTMFs. Manage assigned studies; create and maintain the TMF Plan and TMF Index, monitor document submissions and quality issues workflows and delivery monthly Health reports/CRO metrics / Key Performance Indicators, along with strategy / summary of way to improve. Manage activities within electronic TMF Management system including: Study set-up, milestones, events, lifecycles, oversee and monitor the completion of study / country / site Completeness reviews, trigger Archival activities at the study close, perform ad hoc system trainings and demos as required for TMF leads, assigned study teams and/or CRO Partners. Trigger and manage the activities related to archiving of TMF documents, including obtaining approval from the study team, notifying the Eisai Archivist, and maintaining electronic logs which contain the location of study documents. Oversee the TMF Completeness activities associated with reviews / updates to the EDLs to ensure adherence to SOPS and regulatory requirements. Assist with generating various reports, metrics and analyzing trends across studies, countries, and sites. Oversee the project teams to ensure the Eisai study team and outsourced CRO are compliant with eTMF Processes/Procedures and/or management for the correction and resolution of quality issues, TMF completeness and timely submission of documents to the TMF. Assist or initiate improvements of departmental SOPs, SWPs, work guidelines or trainings as needed.

Requirements: Bachelor's degree in Health Administration, Management Information Systems, or closely related scientific or technical discipline plus 2 years of pharmaceutical industry experience in job offered or as Regulatory Documentation Specialist. Also requires 2 years of experience with/using the following (which may have been gained concurrently):

• TMF/eTMF
• ICH and GCP guidelines
• PhlexEView and Veeva Vault
• Delivering Health reports and CRO metrics

Position based in Nutley, NJ but the candidate may work remotely from anywhere in the U.S. Please send resumes to HR Department, Job Code: (R3651) Eisai, Inc., 200 Metro Blvd, Nutley NJ 07110.

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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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