Clinical Quality Control Specialist - Medical Writing
Current- Medical editing and QC specialist with pharmaceutical industry experience- Perform QC, document editing, formatting, data and grammar checks of clinical and regulatory submission documents (e.g., Protocols, CSRs, IBs, Narratives, Briefing Documents) for consistency and data accuracy against source data.- Verify grammar, syntax, style and compliance with style guides, regulatory guidelines and publishing requirements aligned with publish readiness.- Project manage progress of documents of other reviewers as part of overall regulatory submissions to meet aggressive timelines.- Ensure a consistent style of presentation of documents to maintain quality and ease of review.- Ensure timely delivery of submission documents under aggressive timelines- Coordinate quality control reviews of those documents and maintain audit trails of changesHelp ensure a consistent style of presentation of documents to maintain quality and ease of review
