Job Description

Top 3 things the manager is looking for: 

1. Solid understanding of clinical evaluation and EU MDR.Independently project manage 
2. Previous PSUR writing experience or experience writing documents relevant to EU MDR
3. Works independently with general supervision on larger, moderately complex projects / assignments

Top 3 Tasks or Responsibilities in scope for this role:

1. Ability to draft and author PSUR from start to finish
2. 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)
3. Communicates primarily and frequently with internal contacts. Big picture thinking with problem solving skills

University degree with minimum two years’ experience. Masters level preferred

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. 

• 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.

Job Tags

Remote job, Contract work,

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