Medical Writer

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.