Medical Writing Operations Manager

Job Description

Job Summary:

• The Manager, Medical Writing Operations provides support to Medical Writing functions to ensure high-quality, submission-ready documents.
• Responsibilities include document quality review, formatting and consistency, publishing, and archiving within central file systems.
• The role may also support vendor oversight, training, and the development and maintenance of tools and training materials for Medical Writing Operations.

Duties and Responsibilities:

• Collaborate across functions to collect, compile, assemble, and publish CSR appendices.
• Perform electronic publishing QC, including hyperlinks and bookmarks, to meet submission-ready guidelines.
• Format MS Word submission components per style and regulatory requirements; troubleshoot formatting issues.
• Serve as SME for format QC, submission readiness (protocols, IBs, CSRs), and document management systems.
• Ensure documents are stored and archived appropriately in EDMS and eTMF systems.
• Perform content QC of medical writing documents (e.g., CSRs, IB clinical sections, NDA/MAA clinical sections, protocols).
• Support creation, maintenance, and updates of templates, style guides, and tools to meet global regulatory requirements.
• Perform administrative tasks to support projects and operational needs.
• Participate in development and maintenance of internal best practices.
• Support development, implementation, and maintenance of medical writing systems and software.
• Assist with training of internal staff and external contractors/CROs.
• Support vendor oversight for medical writing operations activities.
• Support updates to Medical Writing intranet pages as needed.
• Assist with CSR shells and/or preparation of in-text tables and figures under medical writer oversight.

Education and Experience:

• Bachelor’s degree in a relevant scientific/technical field or equivalent experience.
• 4+ years of biotech/pharma or CRO experience in document QC and electronic publishing within a regulatory environment.
• Experience with electronic document management systems.

Knowledge, Skills and Abilities:

• Strong understanding of health authority/ICH PDF and eCTD requirements.
• Proven ability to manage multiple projects in a fast-paced, deadline-driven environment.
• Detail-oriented with strong analytical, problem-solving, and flexibility skills.
• Ability and confidence to learn new software tools.
• Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows.
• Exposure to Starting Point templates, SharePoint, EndNote, and Toolbox Pharma preferred.

Alignment with Client Core Values:

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