Contact: Alexandra Spink - aspink@penfieldsearch.com
No 3rd party candidates
Our client is seeking a Medical Writing Editor to support quality control (QC) review, copyediting, and submission readiness for clinical and regulatory documents. This role partners with Medical Writers and cross-functional teams to ensure deliverables meet sponsor standards and applicable regulatory guidance, while also supporting QC operations, process improvement, training enablement, document compilation, and lay summary and redaction activities.
Primary Document Types Supported
Support QC/editing and submission readiness for a range of clinical/regulatory deliverables, including:
- 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.
