Regulatory QC Documentation Specialist

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 :

Key Responsibilities :