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Technical Writer Clinical Evaluations

Job LocationHull
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

This role will ensure generation of documents in line with EU MDR project schedule. Role includes creating compliance documents such as Clinical Evaluation Reports, Clinical Evaluation Plans, Summary of Safety & Clinical Performance and other relevant clinical documentation to be submitted to notified bodies. Appropriate compliance is mandatory to retain products marketed within Europe.Role Overview:The purpose of this role is to use medical writing and literature review experience to generate Clinical Evaluation Reports (CERs) and other associated clinical documents such as the Summary of Safety and Clinical Performance (SSCP) and Clinical Evaluation Plan (CEP), in accordance with the appropriate regulatory standards to ensure continued CE registration of our products.Responsibilities:Leads completion of clinical evaluation reports (CERs), SSCPs, and CEPs for CE registration; including guidance to less experienced team members 60%Works with internal teams to gain cross-functional inputs and approvals into evidence evaluation documentation activities 15%Generates and maintain reference databases 10%Supports the periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives. 10%Support the registration of products in non-EU countries 5%Education: Bachelors in a relevant discipline required. Masters degree or PhD preferred.Experience:

  • Minimum 2 years’ experience (academic or commercial)
  • Proven experience of performing literature reviews, analysing data sets and communicating the outputs.
  • Experience working within a medical devices or pharmaceutical organisation in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
  • Experience in writing scientific documents for regulatory or journal submissions
  • Experience in presenting scientific/clinical evidence in a written and oral manner to cross-discipline teams.
  • Competences:
  • Excellent scientific writing skills.
  • Strong data extraction and analysis skills.
  • Good communicator and able to work collaboratively as part of a team.
  • Self-motivated and able to work independently.
  • Excellent time management skills and ability to work under pressure to deadlines.
  • Must exhibit high quality, ethical and compliant work habits.
  • Experience in using Microsoft Word, Excel, PowerPoint.
  • Experience in reference management software.
  • Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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