Manager Medical Writing Job at Integrated Resources, Inc ( IRI ), Cambridge, MA

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  • Integrated Resources, Inc ( IRI )
  • Cambridge, MA

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

Job Tags

Contract work, For contractors,

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