Electronic Submission Specialist
Company: Patel Consultants Corp
Posted on: July 15, 2019
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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