Manager, Medical Writing Operations

Manager, Medical Writing Operations

Overview

The Manager, Medical Writing Operations supports Medical Writing functions to ensure the delivery of highquality, submissionready documents. Core responsibilities include document quality review, formatting and consistency checks, electronic publishing, and archiving within centralized file systems. The role may also contribute to vendor oversight, training, and the development and maintenance of tools and training materials for Medical Writing Operations.

Key Responsibilities

Document Preparation & Quality Control

• Collaborate crossfunctionally to collect, compile, assemble, and publish CSR appendices
• Perform electronic publishing QC (e.g., hyperlinks, bookmarks) to ensure submissionready compliance
• Format MS Word submission components according to style and regulatory requirements; troubleshoot formatting issues
• Serve as a subject matter expert (SME) for format QC, submission readiness (protocols, IBs, CSRs), and document management systems
• Conduct content QC of medical writing documents, including CSRs, IB clinical sections, NDA/MAA clinical sections, and protocols

Document Management & Systems

• Ensure proper storage and archiving of documents in EDMS and eTMF systems
• Support development, implementation, and maintenance of medical writing systems and software
• Assist with updates to Medical Writing intranet pages
• Support creation, maintenance, and updates of templates, style guides, and tools to meet global regulatory requirements

Operational & CrossFunctional Support

• Perform administrative tasks to support project and operational needs
• Participate in the development and maintenance of internal best practices
• Assist with training internal staff and external contractors/CROs
• Support vendor oversight for medical writing operations activities
• Assist with CSR shells and/or preparation of intext tables and figures under medical writer guidance

Qualifications

Education & Experience

• Bachelor's degree in a relevant scientific or technical field, or equivalent experience
• 4+ years of biotech/pharma or CRO experience in document QC and electronic publishing within a regulatory environment

Technical Skills

• Strong understanding of health authority/ICH PDF and eCTD requirements
• Experience with electronic document management systems
• Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows
• Ability and confidence to learn new software tools
• Preferred: Experience with StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma

Professional Skills

• Proven ability to manage multiple projects in a fastpaced, deadlinedriven environment
• Exceptional attention to detail with strong analytical and problemsolving skills
• Flexible, adaptable, and able to work effectively across teams

Core Values Alignment

• Commitment to People
• Fiercely Innovative
• Purposeful Urgency
• Open Culture
• Passion for Excellence

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