Job Description
Everest is seeking a committed, skilled, and customer‑focused individual to join our winning team as a Senior Medical Writer for our Toronto/Markham, Ontario, Canada on‑site location, or remotely from a home‑based office anywhere in Canada in accordance with our Work from Home policy.
Key Accountabilities
- Author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications, etc., and clinical trial activities. These documents include briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, Clinical Study Reports (CSRs; full, abbreviated or synoptic), Development Safety Update Reports (DSURs)/annual reports, and Investigator’s Brochures (IBs).
- Develop initial document shells or drafts using appropriate and approved templates and adhering to Everest or sponsor’s writing styles and formats.
- Provide a...
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