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GXpeople are looking for a Medical writer to join our client on a permanent basis who are a global medical device manufacturer.

This will be a remote position with some travel spread througout the year

The Associate Medical Writer 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.

Key Responsibilities: Essential functions of the position include but are not limited to the following, other duties may be assigned.

* 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.

* Effective communicator. Able to convey messages logically and concisely.

* Ability to work to deadlines, be self-motivated and well organised.

* Ability to formulate reports and present findings.

* Attention to detail, systematic and orientation toward careful meticulous work.

* Strong familiarity with Microsoft Office.

* Data mining and analysis skills.

* Working cross functionally to assist in the collection Post Market Clinical Data.

Preferred

* Experience writing and/or contributing to Periodic Safety Update Reports.

* Ability to understand and interpret results of clinical studies, with a strong understanding of statistics.

* Ability to prioritize and manage multiple projects.

* Understands how clinical activities can support the business in meeting its business goals.

* When required, effectively work in a cross functional team.

* Knowledge within Medical Device regulatory legislations and standards.

Please get in touch or apply to this advert for more information