The Role
Prepares, publishes, quality reviews, and submits regulatory dossiers for drug, biologic, device, and combination products. Maintains audit-ready regulatory files, Trial Master Files, electronic filing records, and paper archives. Supports FDA submissions, regulatory mailbox administration, document control, validation reporting, and external partner guidance. The role requires five years of administrative experience, Microsoft Office proficiency, U.S. citizenship, a successful background investigation, and eligibility for a government security clearance.
Summary Generated by Built In
Document Control and Quality Specialist
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.
Qualifications:
- Education:
- TBD
- Licensure & Certifications (Current & Unrestricted):
- TBD
- Experience:
- 5 years of administrative experience.
- Proficient use of Microsoft Word, PowerPoint, Excel, and Outlook.
- Manage transport and digitation of paper records, this task may require the ability to lift up to 25 pounds.
- Security & Background Check:
- U.S. Citizenship and a successful background investigation are required.
- Ability to obtain and maintain a government security clearance.
- Additional Requirements:
- Willingness to comply with the government vaccination requirements.
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Compensation: $55k - $58k
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CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.
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Skills Required
- Five years of administrative experience
- Proficiency with Microsoft Word, PowerPoint, Excel, and Outlook
- Ability to transport and digitize paper records
- Ability to lift up to 25 pounds
- U.S. citizenship
- Successful background investigation
- Ability to obtain and maintain a government security clearance
- Willingness to comply with government vaccination requirements
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The Company
What We Do
CICONIX is a veteran-owned small business that provides business advisory and technical assistance, with an emphasis on military and Veterans healthcare programs. Its services span medical research and development, operational medicine support, health information management and technology, organizational development and training, clinical support, program development and management advisory services, Lean training, and healthcare talent acquisition for government and healthcare clients.
