Clinical Evaluation Report Specialist
1 month ago
Estimated Salary: $90,000 - $110,000 per year.
About the Role:
We are seeking a Medical Writer with expertise in healthcare and pharmaceutical industries to join our team for 3 months. The ideal candidate will have experience in translating complex scientific and clinical information into clear and concise documents.
Key Responsibilities:
- Communicate medical and scientific information to various audiences, including healthcare professionals, regulatory agencies, and the public.
- Prepare and edit clinical study protocols, clinical study reports, investigator brochures, and other regulatory documents for submission to health authorities.
- Contribute to the development of manuscripts, abstracts, and posters for publication in scientific journals and presentations at conferences.
- Communicate complex scientific and medical information in a clear and understandable manner for diverse audiences.
- Prepare safety-related documents such as periodic safety update reports (PSURs), risk management plans, and other safety documents required for regulatory submissions.
- Collaborate with cross-functional teams to compile and write sections of regulatory submissions, such as New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and Investigational New Drug (IND) applications.
Requirements:
- 10+ years medical writing experience.
- PHD is preferred.
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