Medical Writing Operations Manager

Job Summary

The Manager, Medical Writing Operations supports Medical Writing functions to ensure the delivery of high-quality, submission-ready regulatory documents. This role is responsible for document quality control, formatting, electronic publishing, archiving, and operational support across medical writing activities. The position also contributes to vendor oversight, training, and the development and maintenance of tools, templates, and best practices that support global regulatory submissions.

Key Responsibilities:

Document Preparation & Publishing

• Collaborate cross-functionally to collect, compile, assemble, and publish Clinical Study Report (CSR) appendices.
• Perform electronic publishing quality control (QC), including hyperlinks, bookmarks, and PDF compliance, to ensure submission-ready documents.
• Format Microsoft Word submission components in accordance with internal style guides and regulatory requirements; troubleshoot complex formatting issues.
• Support CSR shells and assist with preparation of in-text tables and figures under medical writer oversight.

Quality Control & Submission Readiness

• Perform content QC of medical writing documents, including CSRs, Investigator’s Brochures (IBs), protocols, and NDA/MAA clinical sections.
• Serve as a subject matter expert (SME) for document formatting QC, submission readiness, and regulatory document standards.
• Ensure compliance with health authority, ICH, PDF, and eCTD requirements.

Document Management & Archiving

• Ensure documents are stored, versioned, and archived appropriately within Electronic Document Management Systems (EDMS) and eTMF systems.
• Support document lifecycle management and submission traceability.

Tools, Templates & Best Practices

• Support the creation, maintenance, and continuous improvement of templates, style guides, and tools aligned with global regulatory requirements.
• Participate in the development and maintenance of internal best practices for Medical Writing Operations.
• Support development, implementation, and ongoing maintenance of medical writing systems and software.

Training & Vendor Oversight

• Assist with training of internal staff and external contractors/CROs on tools, templates, and operational processes.
• Support vendor oversight activities related to medical writing operations.
• Contribute to updates and maintenance of Medical Writing intranet pages.

Operational Support

• Perform administrative tasks to support project execution and operational needs.
• Manage multiple projects simultaneously in a fast-paced, deadline-driven environment.

Qualifications

Education

• Bachelor’s degree in a scientific, technical, or related field, or equivalent relevant experience.

Experience

• Minimum of 4 years of experience in biotech, pharmaceutical, or CRO environments.
• Hands-on experience in document QC and electronic publishing within a regulated environment.
• Strong understanding of regulatory submission requirements, including ICH, PDF, and eCTD standards.
• Experience working with electronic document management systems.

Skills & Competencies

• High attention to detail with strong analytical and problem-solving skills.
• Ability to manage multiple priorities with flexibility and a sense of urgency.
• Confidence and aptitude to learn and adapt to new software tools and systems.
• Strong collaboration and communication skills.

Technical Skills

• Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and Windows.
• Experience or exposure to StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma preferred.