Medical Writing Operations & Quality Control

Contact: Alexandra Spink -
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.