Medical Writing Operations & Quality Control - Remote

Contact:
Alexandra Spink - aspink

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.