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Staff Medical Writer (Remote)
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Full-time
Remote
- This is an individual contributor fully Remote position, located in the United States.
- As a Staff Medical Writer, you will work closely with cross-functional teams (Marketing, Research and Development, Regulatory, and Quality) to create literature reviews and reports to support global pharmacovigilance activities.
- Interpret and synthesize the information in clinical regulatory documents, in compliance with global requirements, including pharmacovigilance.
- Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta-analyses, or other sources of safety and performance data (e.g. investigator-initiated study clinical data) and synthesize the information in support of European Medical Device Regulation (EU MDR).
- Collaborate cross-functionally to provide input for design teams clinical EU MDR requirements.
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