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Medical Writing Operations Associate
at Vertex Pharmaceuticals Inc (US)
Boston, MA

Medical Writing Operations Associate
at Vertex Pharmaceuticals Inc (US)
Boston, MA

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The Medical Writing (MW) Operations Associate ensures quality review of clinical and regulatory documents and MW process documentation. The MW department plays an integral role in producing scientifically accurate, high-quality clinical documents throughout the drug development process.


  • Performs advanced editing, formatting, fact-checking, and content quality control reviews of regulatory and clinical study documents (e.g.,clinical study reports and protocols, Investigator's Brochures, and regulatory submission modules) according to department guidelines
  • Works with other functions to collect, file, and track appendices for clinical study reports using the electronic document management system (eDMS)
  • Provides troubleshooting and training to all levels on key MW processes and systems
  • May develop and update SOPs, work instructions, templates, and checklists
  • May supervise or lead MW initiatives related to document development, quality, and improvement (such as managing systems, collecting and analyzing metrics, or developing and implementing new tools)
  • Communicates ideas for new processes and/or business operations for process improvement

Minimum Qualifications :

  • Outstanding attention to detail related to consistency, grammar, and accuracy according to source documentation
  • Working knowledge of Microsoft Office (including Word, PowerPoint, and Excel)
  • Previous experience with eDMS, electronic Common Technical Document (eCTD) Viewer, Good Clinical Practice (GCP), and the AMA Manual of Style is a plus
  • Ability to complete work in a resourceful, self-sufficient manner, with some guidance and mentoring on new or complex issues
  • Exhibits sound judgement and decision-making in a dynamic, regulated environment


B.A. (or equivalent degree) with 1to 2years of relevant work experience preferred

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