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Medical Writing Operations Manager

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Proclinical

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Location:
United States , Cambridge

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

70.00 - 77.00 USD / Hour
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Job Description:

Be the backbone of innovation and join a leading pharmaceutical company to help keep life-changing science moving forward! Proclinical is seeking a Medical Writing Operations Specialist to support the creation, quality review, and management of submission-ready documents. This role involves ensuring document consistency, formatting, and compliance with regulatory standards, as well as contributing to operational excellence within medical writing functions.

Job Responsibility:

  • Collaborate across teams to collect, compile, and publish Clinical Study Report (CSR) appendices
  • Perform quality control (QC) checks on electronic publishing, including hyperlinks and bookmarks, to meet submission guidelines
  • Format MS Word documents according to style and regulatory requirements, troubleshooting formatting issues as needed
  • Act as a subject matter expert (SME) for format QC, submission readiness protocols, Investigator Brochures (IBs), CSRs, and document management systems
  • Ensure proper storage and archiving of documents in electronic document management systems (EDMS) and electronic trial master file (eTMF) systems
  • Conduct content QC for medical writing documents, such as CSRs, IBs, clinical sections of NDAs/MAAs, and protocols
  • Support the creation, maintenance, and updates of templates, style guides, and tools to align with global regulatory requirements
  • Perform administrative tasks to support projects and operational needs
  • Contribute to the development and maintenance of internal best practices
  • Assist in the implementation and upkeep of medical writing systems and software
  • Provide training to internal staff and external contractors/CROs
  • Support vendor oversight for medical writing operations activities
  • Update Medical Writing intranet pages as needed
  • Assist with CSR shells and preparation of in-text tables and figures under medical writer guidance

Requirements:

  • Background in a relevant scientific or technical field, or equivalent experience
  • Experience in document QC and electronic publishing within a regulatory environment
  • Strong understanding of health authority, ICH, PDF, and eCTD requirements
  • Familiarity with electronic document management systems
  • Proven ability to manage multiple projects in a fast-paced, deadline-driven environment
  • Detail-oriented with strong analytical, problem-solving, and adaptability skills
  • Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows

Nice to have:

Exposure to tools like StartingPoint templates, SharePoint, EndNote, and Toolbox Pharma is preferred

Additional Information:

Job Posted:
January 07, 2026

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