About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact.
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Location(s): Fort Detrick, MD
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Position Details:
Full-time position
Regular weekly hours (0900-1600)
No calls, nights, weekends, or holidays!
Full benefit program, including: health, PTO, & 401k + contribution
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Requirements:
TBD
Summary:
CICONIX is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD. The Document Control and Quality Specialist will prepare, publish, and submit documents in accordance with all pertinent laws, regulations, guidance documents, best practices, and policies for drug, biologic, device, and combination product types; provide document control and archiving support for electronic and paper records; and provide publishing, submission, and document control subject matter expertise to ORA and its external partners.
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About the Role:
Prepare documents for publishing and submission to regulatory agencies in the required formats, including electronic Common Technical Document, eCOPY, or Electronic Submission Template and Resource (eSTAR) or preSTAR formats.
Publish dossiers that comply with the applicable regulations, policies, guidance documents, formats, and standards, sometimes with short timelines, to meet regulatory deadlines. Provide Validation reports on the published output.
Perform quality reviews and provide feedback on published dossiers.
Submit dossiers to the US FDA through the Electronic Submission Gateway and other methods as required.
Create and maintain audit ready regulatory files and Trial Master File (TMF).
Assist the Government by maintaining the Sponsor’s Regulatory Mailbox. The Contractor shall upload the Sponsor’s documents to the Sponsor’s Electronic Regulatory Filing (SERF) in the EDMS. Once the document is uploaded the Contractor will notify the sender that the document was uploaded to SERF.
Participate in project meetings and communications and provide subject matter expertise and guidance to ORA and external team members.