Position Title: Regulatory QC Documentation Specialist
Work Location: Remote
Assignment Duration: 12 months (possible extension)
Work Arrangement: Fully remote, 9:00 AM - 3:00 PM CST (40 hours per week)
Position Summary:
- Quality Control Position / no writing
- The team has 17 members (mix of remote and local staff) working across all therapeutic areas depending on project needs.
- Candidates must be independent and self-driven, able to self-assign projects, communicate with medical writers, and complete reviews with minimal supervision once trained.
- This position is fully remote and requires candidates to be available to start on January 5th.
- It is a Quality Control-focused position within Medical Writing, not a writing-heavy role.
- Involves QC review of clinical and regulatory documentation, such as investigator brochures, protocols, and other submission documents.
- The emphasis is on verification and consistency checks ensuring accuracy of data and alignment with source documents.
- QC here does not refer to formatting or editing; the focus is on content verification and factual accuracy.
- The QC Reviewer ensures that data, text, and conclusions are consistent across sections and match approved sources.
Qualification & Experience:
- Bachelor's degree required. Bachelor's in Science, English, or Communication preferred. Higher education (Master's or PhD) acceptable if relevant QC experience is present.
- 2-3 years in quality control/review of clinical regulatory documents or related experience in quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D.
- Strong knowledge of clinical and regulatory documentation and CTD/eCTD structure.
- Proficiency with Microsoft Word, Veeva Vault, and regulatory management systems.
- Knowledge of drug development and experience with Common Technical Document (CTD) templates.
Key Responsibilities:
- Defines scope of quality control activities with the document author and identifies required source documents and data.
- Conducts independent quality control review of documents per applicable checklist by checking against source documents to ensure results are accurate.
- Ensures quality control documentation is complete and uploaded to the master file per established business processes.
- Maintains knowledge of clinical regulatory documents requiring QC review and related business processes.
- Interacts daily with medical writers, managers, and applicable cross-functional teams.
- Communicates and provides deliverables to medical writers, managers, and others as applicable.
- Prepares technical documents to support both domestic and international regulatory submissions, incorporating text, graphs, charts, tables, and statistical analysis.
- Proofreads, circulates, edits, assembles, inspects, and duplicates product submissions.
|
Spectraforce Technologies
Nov 10, 2025