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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