We found 6 Regulatory Reporting jobs in Ashburn
Regulatory Reporting in Ashburn
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* Format documents including IND/BLA/NDA/ sections, protocols, amendments, investigator brochures, meeting packages, etc. for regulatory submissions.
* Assist regulatory group in the submission of regulatory documents and performs quality control review of final documents to regulatory agency.
* Assist to ensure document quality and timeliness and identify, assess, and resolve or escalate any risks or issues that could affect the successful completion of regulatory submissions/timelines.
* Develop and maintain regulatory document processing and regulatory submission publishing standards and procedures (SOPs)
* Manage all regulatory submission publishing deliverables on a day-to-day basis to ensure successful execution of operational activities
* Work independently to drive publishing process for routine submissions and proactively identifies and escalates publishing issues as necessary.
* Regulatory document level publishing including: editing, formatting (MS Word: styles, captions, cross-references, tables, etc.), conversion of files to required standards, Adobe PDF processing: book marking; hypertext linking; and quality control checks.
* Submission level publishing including: eCTD placement and structure within eCTD Modules (1-5), cross-document links, study tagging files (STF), submission quality control (QC), transmission of submissions to US FDA via Electronic Submissions Gateway (Global Submit).
* Archive and document transfer: archival of final word documents and submission sequence, maintain regulatory administrative record (submission calendar, log, etc.)
* Maintain proficiency and expertise with respect to eCTD publishing tools, processes, and regulations associated with global eCTD regulatory submissions.