Collaborating with Authors/ GRL/ SMRA/ PMRA for document readiness activity. Formatting of documents for all disciplines contributing to Regulatory Dossiers and all products Creating and updating Virtual Documents. Creating and verifying bookmark structure and hyperlinks to ensure submission-readiness of submission relevant documents. Supporting stakeholders with required literature via ordering at Scientific Library, formatting, uploading, approving. Report publishing for all safety reports, clinical safety management plans as well as nonclinical reports via publishing tool. Point of contact for supporting all stakeholders in eDMS related questions. Being able to independently resolve routine and complex issues with minimal guidance. Assuring that submission documentation meets registration needs and timelines. Managing lifecycle of the documents Manage and maintain templates in the VEEVA system Prepare the submission readiness in VEEVA system
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