Remote Medical Writer
Virtual Location Coon Rapids, MN 55448 US
Job Description
Top 3 things the manager is looking for:Â
- Solid understanding of clinical evaluation and EU MDR.Independently project manageÂ
- Previous PSUR writing experience or experience writing documents relevant to EU MDR
- Works independently with general supervision on larger, moderately complex projects / assignments
- Ability to draft and author PSUR from start to finish
- Well versed in using Microsoft word and Template use (Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities. Compiles, analyzes, and summarizes additional data from other sources as needed)
- Communicates primarily and frequently with internal contacts. Big picture thinking with problem solving skills
University degree with minimum two years’ experience. Masters level preferred
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Medical Writer for EU MDR. Writes and edits documents for EU MDR clinical and post-market surveillance documents (CEP, SSCP, PSUR),or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication.Â
• Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities.Compiles, analyzes, and summarizes additional data from other sources as needed. Solid understanding of MEDDEV and EU MDR.
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