
Clinical Technical and Medical Writer
Perform comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies and stay informed about applicable clinical landscapes and trends. Combine an understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge to support Regulatory Affairs submissions for CE marking of new devices and maintaining CE marks for existing devices. Extracts data from included studies, interpret study results, synthesizes literature, and prepares summaries into formal reports. Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs). Manage CER timelines required by product development teams and global regulatory bodies by utilizing the appropriate project management tools.
Experience writing study protocols and final study reports
2 years experience in clinical evaluation report writing (CER) in the medical device industry is required.
Strong knowledge of orthopedic medical and surgical terminology
Documentation
Time Management
MS Word
MS PowerPoint
Technical writing skills
MS Excel skills
Pubmed
Embase
Process Improvement
Verbal communication
written communication
Adaptability
Detail Oriented and Organized
According to JobzMall, the average salary range for a Clinical Technical and Medical Writer in 1951 J and C Blvd, Naples, FL 34109, USA is $38,828 - $77,656 per year. This range is based on salaries submitted by users to the JobzMall website. Salaries may vary depending on experience, location, and other factors.
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Arthrex, an orthopedic medical device company, is a leader in product development, medical education and a pioneer in arthroscopy, having developed thousands of products and surgical procedures in orthopedic medicine worldwide.

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