Medical Writer

GxPeople Global
Harrogate, ENG Full Time
POSTED ON 9/21/2024 CLOSED ON 10/19/2024

Job Posting for Medical Writer at GxPeople Global

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

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