Clinical Evaluation Report Writer (Home based)

  • Maetrics Limited
  • London, UK
  • 01 Nov, 2020
Full Time Media-Journalism

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

  • 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

  • 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

Maetrics offers competitive salaries with excellent benefits...... click apply for full job details