Manager, Medical Writing Operations

Overview

• Manage medical writing operations to ensure submission-ready documents meet high-quality standards and regulatory requirements.
• Support document formatting, consistency, publishing, and archiving within central file systems.
• Collaborate with cross-functional teams to compile and publish CSR appendices.
• Perform quality control checks for electronic publishing, hyperlinks, and bookmarks.
• Develop and maintain tools, templates, and training materials for medical writing operations.
• Support vendor oversight and training for internal staff and external contractors.
• Assist with CSR shells and preparation of in-text tables and figures.
• Ensure compliance with global regulatory requirements and internal best practices.

Key Responsibilities & Duties

• Collaborate across functions to collect, compile, and publish CSR appendices.
• Perform electronic publishing QC, including hyperlinks and bookmarks, ensuring submission readiness.
• Format MS Word submission components per style and regulatory requirements.
• Serve as SME for format QC, submission readiness, and document management systems.
• Ensure documents are stored and archived appropriately in EDMS and eTMF systems.
• Support creation and updates of templates, style guides, and tools.
• Perform administrative tasks to support projects and operational needs.
• Assist with training internal staff and external contractors/CROs.

Job Requirements

• Bachelor’s degree in a relevant scientific or technical field.
• 4+ years of experience in biotech/pharma or CRO document QC and publishing.
• Strong understanding of health authority/ICH PDF and eCTD requirements.
• Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows.
• Experience with electronic document management systems.
• Ability to manage multiple projects in a deadline-driven environment.
• Exposure to StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma preferred.
• Alignment with core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence.