Medical Writing Word Processing Coordinator

Position Title: Medical Writing Word Processing Coordinator

Work Location: 100% Remote

Assignment Duration: 12 Months

Position Summary: The Medical Writing Word Processing Coordinator is responsible for formatting, proofing, and completion of Clinical Protocols, Clinical Study Reports, Investigator's Brochures, and other related clinical regulatory documents.

Background & Context:

• Provides document formatting support to Medical Writing, Clinical, and other functional areas, ensuring successful preparation of high-quality, submission-ready documents.
• Ensures completion of work to meet multiple client deadlines.
• Ensures styles and formatting are consistent with defined eSubmissions standards so that the documents created in MS Word correctly render to PDFs.
  
  Key Responsibilities:
• Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency.
• Communicates regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, eSubmissions issues, and document completion dates.
• Provides ongoing support for Medical Writing, Clinical, and other functional areas; acts as a liaison between eDocs support and Medical Writing as needed.
• Responsible for effective communication among team members.
• Ensures all electronic document deliverables are processed and completed in alignment with timelines.
• Accountable for meeting the main objectives of assigned word processing projects within established timelines and with an appropriate quality level.
• Ensures document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs.
• Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable.
• Accountable for providing services and results on time, accurately and consistent with expectations.
• Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions.
• Accurately and timely maintains document tracking for all documents.
• Ensures literature citations are correct.
• Performs literature searches.
• Maintains knowledge of eSubmissions styles and formatting standards.
• Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
• Participates in process improvement activities.
  
  Qualification & Experience:
• A minimum of 3 years of relevant industry experience within medical writing in a global pharma, biotech, life science, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
• Strong expertise in Microsoft Word, Adobe Toolbox, DocX tools, and template layout design.
• Deep familiarity with style guide application, formatting per eCTD standards, and Word-to-PDF rendering.
• Must understand document styling, template integrity, and how to use tools like COSMOS and Smartsheet.
• Ability to self-assign tasks, manage deadlines, and adapt quickly to last-minute formatting requests.
• Experience in proofreading, applying brand styles, and ensuring consistency with submission formatting standards.
• Comfortable working across multiple time zones (PST, CST, EST) with primary alignment to CST hours.