Medical Writing Operations & Quality Control

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

We are seeking a hands-on, detail-oriented professional to support Quality Control (QC), submission readiness, and medical writing operations. This role will partner closely with the Head of Medical Writing and QC team to ensure high-quality, compliant clinical and regulatory documents while optimizing vendor workflows and operational processes.

This is a multi-hat role, with responsibilities spanning QC, document publishing, CSR appendices, redaction, lay summaries, and submission readiness - not QC alone.

Key Responsibilities

• Lead QC of clinical and regulatory documents, including protocols, CSRs, IBs, clinical summaries, and plain language materials.
• Support submission readiness and document publishing, including document completeness, consistency, formatting, version control, bookmarks, hyperlinks, tables of contents, pagination, and other final production elements.
• Coordinate and QC CSR appendices, including completeness, consistency, formatting, and submission-ready preparation. Hands-on CSR appendix experience is a key requirement.
• Review Tables, Listings, and Figures (TLFs) and supporting clinical documentation for accuracy, consistency, formatting, and alignment with the primary document.
• Identify and troubleshoot document production issues and work with writers, vendors, and other stakeholders to resolve.
• Utilize document publishing and production tools (e.g., ISI Toolbox or similar systems) to support document preparation, navigation, and submission readiness.
• Manage document redaction activities to support global transparency and disclosure requirements.
• Support development and QC of lay/plain language summaries, including Plain Language Protocol Summaries and other patient-facing materials.
• Support dashboards, metrics, and continuous improvement initiatives across the Medical Writing function.
• Collaborate cross-functionally to ensure high-quality, compliant, audit- and submission-ready documentation.

Qualifications

• Advanced degree in life sciences (PhD or PharmD preferred).
• 7+ years of experience in medical writing, QC, publishing, and/or medical writing operations within pharma, biotech, or CRO environments.
• Strong experience with QC, CSR appendices, document publishing, and submission readiness.
• Working knowledge of TLFs and clinical study documentation, with the ability to identify inconsistencies and production issues.
• Experience with document production tools such as ISI Toolbox or similar publishing systems; familiarity with bookmarks, hyperlinks, TOCs, and other submission-ready document features.
• Expertise in redaction and document compliance/transparency requirements.
• Experience with lay/plain language summaries and clinical/regulatory documents.
• Solid understanding of ICH/GCP and familiarity with document management systems.
• Strong operational mindset with experience improving processes and managing vendors.
• Excellent attention to detail, organization, and ability to manage multiple priorities and contribute across functions.