Clinical Documentation Specialist

2 days ago

Harrogate, North Yorkshire, United Kingdom GxPeople Global Full time

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

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