Medical Writer (Regulatory)

ODC Pharma
ODC Pharma
, United States

Medical Writer (Regulatory)

Prepare clinical documents including: clinical summaries of marketing applications, integrated summaries of safety and efficacy, CSR's, study protocols, IB's, aggregate safety reports, and manuscripts.

Qualifications:

  • Bachelor’s Degree or higher.
  • Min 5 years of medical writing experience.
  • Working knowledge of ICH and other regulatory guidelines required. 
  • Ability to present clinical data, strong communication skills.
  • Strong regulatory writing skills and keen attention to detail required.

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