Medical Writing Operations Manager

• Collaborate across teams to collect, compile, and publish Clinical Study Report (CSR) appendices
• Perform quality control (QC) checks on electronic publishing, including hyperlinks and bookmarks, to meet submission guidelines
• Format MS Word documents according to style and regulatory requirements, troubleshooting formatting issues as needed
• Act as a subject matter expert (SME) for format QC, submission readiness protocols, Investigator Brochures (IBs), CSRs, and document management systems
• Ensure proper storage and archiving of documents in electronic document management systems (EDMS) and electronic trial master file (eTMF) systems
• Conduct content QC for medical writing documents, such as CSRs, IBs, clinical sections of NDAs/MAAs, and protocols
• Support the creation, maintenance, and updates of templates, style guides, and tools to align with global regulatory requirements
• Perform administrative tasks to support projects and operational needs
• Contribute to the development and maintenance of internal best practices
• Assist in the implementation and upkeep of medical writing systems and software
• Provide training to internal staff and external contractors/CROs
• Support vendor oversight for medical writing operations activities
• Update Medical Writing intranet pages as needed
• Assist with CSR shells and preparation of in-text tables and figures under medical writer guidance

• Background in a relevant scientific or technical field, or equivalent experience
• Experience in document QC and electronic publishing within a regulatory environment
• Strong understanding of health authority, ICH, PDF, and eCTD requirements
• Familiarity with electronic document management systems
• Proven ability to manage multiple projects in a fast-paced, deadline-driven environment
• Detail-oriented with strong analytical, problem-solving, and adaptability skills
• Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows

Exposure to tools like StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma is preferred