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Electronic Submission Specialist

Company: Patel Consultants Corp
Location: Summit
Posted on: July 15, 2019

Job Description:

Electronic Submission Specialist Responsibilities will include, but are not limited to, the following 1. Support Global Regulatory Operations Leads in the coordination, preparation, and submission of all INDSNDAsMAAs and life cycle management in eCTD. 2. Responsible for the creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc. 3. Responsible for maintenance of all Regulatory and Health Authority submission archiving within specified time frames. 4. Verification of regulated electronic documents via workflows within Celgene s electronic document management system. 5. Adherence to required submission timelines, health authority publishing specifications, and internal working practices. SkillsKnowledge Required 2 yrs. pharmaceutical industry publishing experience required (MUST specifically be in Regulatory Operations) Experience with compiling eCTD, validating, and verification of eCTD submissions in a publishing tool (eg, eCTDXPress, eCTDManager, ViewPoint, etc) Technical knowledge of electronic publishing systemsdocument management systems and software BABS Degree or equivalent experience Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic Proficiency with MS-Office Suite and Adobe Acrobat applications Knowledge of health authority proceduresguidance s regarding electronic submissions

Keywords: Patel Consultants Corp, New York , Electronic Submission Specialist, Other , Summit, New York

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