Senior Medical Writer/Principal Medical Writer

Added
19 minutes ago
Type
Full time
Salary
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gcp microsoft office ich medical writing fda
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πŸ“‹ Description

  • Lead the development of high-quality and on-time clinical study documents.
  • Clinical document planning, writing, editing/formatting, and performing QC review.
  • Develop documents in compliance with Precision MW Style Guide, Precision SOPs, applicable
  • Plan, write, edit, format, and QC review clinical documents including protocols, IBs, ICF
  • Ensure smooth document management from template to final approved version in collaboration with
  • Independently formulate key messages from clinical study data.

🎯 Requirements

  • BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
  • 5+ years of experience as a Sr. Medical Writer in sponsor and/or CRO setting, or 7+ years as a
  • Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
  • Clear understanding of applicable regulations (ICH, FDA, GCP), clinical trial transparency
  • Impeccable attention to detail and ability to complete writing assignments in a timely manner.
  • Ability to work effectively in a fast-paced environment with multiple high-priority projects with
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