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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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Description

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.

KEY RESPONSIBILITIES:

  • 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 :

TECHNICAL AND COMMUNICATIVE SKILLS:
  • 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

PREFERRED EDUCATION AND EXPERIENCE:

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

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