Medical Writer (Regulatory)
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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