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Clinical Documentation Specialist
2 months ago
Clinical Evaluation Report Writer
**About the Role**
GxPeople Global is seeking a skilled Medical Writer to join our client, a global medical device manufacturer, on a permanent basis. This remote position involves some travel throughout the year.
**Key Responsibilities**
* Produce high-quality clinical documentation to support regulatory submissions and maintain compliance activities
* Assist in the design and distribution of questionnaires to collect post-market clinical follow-up data
* Visit customers and trade shows to collect post-market clinical follow-up data
* Support the wider Regulatory Affairs team as required
**Qualifications and Personal Attributes**
* Scientific background (BSc or above in Biology, Chemistry, Biomedical Engineering, Life Science, or related field)
* Expertise in conducting focused literature searches on PubMed, MedLine, or other similar literature databases
* Experience writing PMCF Plans and Reports to comply with EU MDR 745/2017 and the MDCG Guidelines
* Strong familiarity with Microsoft Office
* Data mining and analysis skills
* Working cross-functionally to assist in the collection of Post Market Clinical Data
**Preferred Qualifications**
* Experience writing and/or contributing to Periodic Safety Update Reports
* Ability to prioritize and manage multiple projects
* Knowledge within Medical Device regulatory legislations and standards
