Job Description

Job Title: Medical Writing Operations Manager

Location: Cambridge, MA

Duration: 10 months contract

Pay rate: $60 - $65/hr.

Job Description:

• 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.

Key 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 development, implementation, and maintenance of medical writing systems and software
• Assist with training of internal staff and external contractors/CROs

Qualifications:

• 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
• Strong understanding of health authority/ICH PDF and eCTD requirements
• Experience with electronic document management systems
• Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows
• Exposure to StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma preferred

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