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Related skills

gcp gdpr hipaa endnote ama style guide

📋 Description

  • Lead planning and production of regulatory docs (protocols, ICFs, CSRs)
  • Coordinate with authors to translate/write/edit data for publication
  • Act as project manager for writing deliverables, track timelines
  • Participate in quality control review of others\' documents
  • Provide publication support with external executives/designers/editors
  • Support study teams with review of training materials when requested

🎯 Requirements

  • Undergraduate degree minimum; 3-5 years medical writing exp
  • Experience leading development of protocols, ICFs, CSRs
  • GCP, GDPR, HIPAA trained
  • Advanced EndNote/reference software knowledge
  • Familiar with graphical software and figure development
  • Adaptable to changing priorities; strong written/oral skills

🎁 Benefits

  • Bonus eligible
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