What are the responsibilities and job description for the Medical Writing Operations Manager position at Meet Life Sciences?
Job Summary
The Medical Writing Operations Manager supports Medical Writing teams to deliver high-quality, submission-ready regulatory documents. This role focuses on document quality control, formatting, electronic publishing, archiving, and operational support, while also contributing to tools, training, systems, and vendor oversight that enable efficient medical writing operations.
Responsibilities
- Collaborate cross-functionally to collect, compile, assemble, and publish clinical study report (CSR) appendices.
- Perform electronic publishing quality control (QC), including hyperlinks and bookmarks, to ensure submission readiness.
- Format MS Word submission documents per style guides and regulatory requirements; troubleshoot complex formatting issues.
- Serve as a subject matter expert for format QC, submission readiness (e.g., protocols, IBs, CSRs), and document management systems.
- Ensure proper storage and archiving of documents within EDMS and eTMF systems.
- Conduct content QC of medical writing deliverables (e.g., CSRs, Investigator’s Brochures, protocols, NDA/MAA clinical sections).
- Develop, maintain, and update templates, style guides, tools, and best practices aligned with global regulatory standards.
- Support medical writing systems, software, and operational processes.
- Assist with training of internal staff and external contractors/CROs.
- Support vendor oversight related to medical writing operations.
- Perform administrative and operational tasks, including intranet content updates and project support.
- Assist with CSR shells and preparation of in-text tables and figures under medical writer oversight.
Qualifications
- Bachelor’s degree in a scientific or technical field, or equivalent experience.
- 4 years of experience in biotech, pharma, or CRO environments supporting document QC and electronic publishing in a regulatory setting.
- Strong knowledge of health authority, ICH, PDF, and eCTD requirements.
- Experience with electronic document management systems (EDMS).
- Experience with StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma preferred.