Medical Writing QC Editor

Contact: Alexandra Spink -

teamnt@penfieldsearch.com

• Clinical Study Reports (CSRs)
• Clinical study protocols and amendments
• Investigator’s Brochures (IBs)
• CTD Module 2 summaries (e.g., clinical summaries/overviews)
• Briefing books and regulatory interaction packages (e.g., Scientific Advice meeting packages)
• PSP/PIP and related lifecycle/regulatory planning documents (as applicable)

Key Responsibilities

• Perform QC review of clinical/regulatory documents to ensure accuracy, completeness, consistency, and compliance with sponsor standards and relevant health authority expectations.
• Verify data and statements against source tables, figures, and listings; support formatting of tables and in-text data consistency checks.
• Copyedit documents for grammar, punctuation, spelling, clarity, and style (e.g., AMA Manual of Style and/or sponsor style guides) using established checklists and best practices.
• Monitor QC timelines for assigned deliverables; proactively communicate risks/issues to the lead medical writer and/or project manager to protect delivery dates.
• Support submission readiness and production: assist with document compilation activities and final quality checks to ensure deliverables are complete, consistent, and ready for submission/dispatch.
• Provide operational support (e.g., job aids, checklists, templates) and contribute to continuous process improvements and SOP-aligned practices.
• Support training enablement (level-dependent): help develop/refine QC guidance and share best practices with writers/editors to improve quality and efficiency.
• Support Medical Writing with appendices and reference compilation and reference QC (completeness, consistency, and formatting per sponsor standards).
• Support disclosure activities (i.e., plain language summary and redaction).

Qualifications

• 5+ years of experience in medical editing/QC within a regulated clinical/regulatory document environment (or equivalent relevant experience).
• Working familiarity with FDA/EU (and other relevant) guidance/industry standards impacting regulatory document quality.
• Demonstrated proficiency in copyediting and QC review for clinical/regulatory deliverables; strong attention to detail and ability to manage multiple priorities under deadlines.
• Experience supporting protocols/amendments, CSRs, IBs, and CTD Module 2 summaries.
• Experience contributing to process improvement tools/templates and SOP-driven editorial practices.
• Experience with compilation/production readiness support for medical writing deliverables.
• Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams.