Medical Writer

Company:  GxPeople Global
Location: Manchester
Closing Date: 01/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
We are looking for PMS- Medical Writing Associates for a client who are a Global Medical Device Manufacturer. You will be responsible for the production of high-quality clinical documentation to support regulatory submissions, maintain compliance activities, support new product development / Design Changes programs, and other projects that may require Clinical participation. This position is permanent and remote although candidates must be based in the UK and have non-expiring right to work in the UK. Essential functions of the position include but are not limited to the following, o The collection, collation, reporting and maintenance of Post Market surveillance data Assist in the design and distribution of questionnaires to collect post market clinical follow up data Visit customers, trade shows to collect post market clinical follow up data Upload the approved documentation into the QMS Support the wider Regulatory Affairs team as required Identify improvements to the clinical processes and procedures Qualifications and Personal attributes: Essential 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. Understands how the clinical activities support the QMS and the lifecycle of products. Excellent written and verbal communication skills. Please get in touch for more information or apply to this advert.
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