Lead QC/Operations Medical Writer

Job Description

Contact: Alexandra Spink - aspink@penfieldsearch.com
No 3rd party candidates

We are seeking a hands-on, detail-oriented professional to support Quality Control (QC) and operational excellence within the Medical Writing function. This role will closely partner with the Head of Medical Writing to optimize vendor processes, drive efficiencies, and uphold the highest standards of quality and compliance across clinical and regulatory documents.

Key Responsibilities

• Lead QC reviews for protocols, CSRs, IBs, clinical summaries, and plain language documents.
• Manage document redactions to ensure global transparency compliance.
• Support or lead the development of Plain Language Protocol Summaries and Lead Author contributions.
• Partner with the Head of Medical Writing to manage vendor workflows, SOPs, and process improvements.
• Maintain and enhance SOPs, templates, and QC tools; support dashboard reporting and metrics tracking.
• Collaborate cross-functionally to ensure high-quality, audit-ready documentation.

Qualifications

• Advanced degree in life sciences (PhD or PharmD preferred).
• 7+ years of experience in medical writing and QC within pharma, biotech, or CRO environments.
• Strong expertise in redaction practices and document compliance.
• Solid understanding of ICH/GCP guidelines and familiarity with document systems.
• Operational mindset with proven ability to improve processes and manage vendor relationships.