Medical Writer / Reviewer

Job Overview

This position is for a Medical Writer located in the UK or Poland, requiring a minimum of 3 years of experience. It involves meticulous quality control (QC) review of clinical sections in various regulatory documents to ensure technical accuracy, regulatory compliance, and consistency.

Key Responsibilities

• Conduct thorough QC reviews of clinical parts of regulatory documents including Investigator's Brochures, Clinical Study Reports, Modules 2 & 5 submissions, narratives, protocols, INDs, NDAs, BLAs, CTAs, MAAs, and briefing packages for regulatory meetings.
• Verify all references and source data precisely to ensure the highest quality standards.
• Ensure internal consistency both within individual documents and across related documentation.
• Perform comprehensive content quality control specifically on clinical data and reports across all therapeutic areas, development phases, and modalities, covering diverse geographic regions.
• Cross-check data presented in text, tables, and figures against source documents for accuracy and consistency, verifying 100% of content including text and visual data.
• Review documents for language quality including grammar, punctuation, spelling, and adherence to client style guides and standards.
• Maintain QC records and checklists for documentation of findings appropriately.

Additional Information

This role requires precision and familiarity with regulatory documentation in clinical research to ensure compliance and technical correctness at every stage of document preparation and review.