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Clinical Evaluation Report Writer (Home based) posted by Maetrics Ltd

Full-Time
London

Job Description

We are currently recruiting for Clinical Evaluation Report Writer’s from the Medical Device industry to join an already established team within Maetrics. This will be a home based role with both permanent and contract opportunities available.
Key Responsibilities of the Clinical Evaluation Report Writer
To join Maetrics CER team in the review and authoring of clinical evaluation reports (CER) for the client
Will be responsible for writing, reviewing and updating the clinical evaluation reports for all client product families
Attend CER initial meetings to gain an understanding of the product from product and technical leads
Liaise with product and technical leads to gather information and data required to complete/update CERs
Liaise with PMS/vigilance leads to gather information and data required for CERs
Submit new, updated and reviewed CER's for internal QC
Attend client review board meetings to answer questions on submitted CERs
Follow Maetrics and Client CER procedures and protocols
Manage follow up questions/actions from the notified body reviewing the CER
Key Requirements of the Clinical Evaluation Report Writer
BA or BS in Life Sciences with at least 5 years of medical writing experience, or MS degree with at least 3 years of medical writing experience, or PhD with at least 2 years of medical writing experience within the medical device industry
Excellent English technical writing and grammar skills
Minimum 3 years' experience writing AND reviewing CERs (Clinical Evaluation Reports)
Experience in either orthopaedics/joint replacements or Trauma and Class III devices
Minimum 2 years' experience writing AND reviewing CEPs (Clinical Evaluation Plans)
Researches and reviews medical and scientific literature, advanced scientific reading, writing and editing skills
Ability to interpret, analyze, and report statistical data from clinical studies to meet regulatory obligations, and for scientific publication or presentation. Attention to detail is paramount
Expertise in searching medical literature and databases for clinical and technical information
Ability to accurately interpret data and present complex information in a clear and concise written manner
Firm understanding of and experience with ANNEX X - Med Dev. Directive
Firm understanding of and experience with Med Dev. 2.7.1 Rev. 4 Guidance document
Authored AND reviewed multiple CERs within the last 12 months which have been submitted to and reviewed by a Notified Body

Reference Number

212637206

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