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Evidence Evaluation Specialist-Tech Writer II


Location: Cordova , Tennessee
Job Category:

12+ month contract 
Role can be remote but Memphis is preferred. 
The purpose of this role is to use medical writing and literature review experience to generate Clinical Evaluation Reports (CERs) and other associated documents in accordance with the appropriate regulatory standards (EU MDR) to ensure continued CE registration of Smith & Nephew products.
Responsibilities:
Leads completion of clinical evaluation reports (CERs), Benefit Risk Analysis (BRAs), Clinical Evaluation Plans (CEPs), and Summary of Safety and Clinical Performance (SSCPs) for CE registration including guidance to less experienced team members 75%
Works with internal teams to gain cross-functional inputs and approvals into evidence evaluation documentation activities 15%
Generates and maintain reference databases 10%

Education: Bachelors in a relevant discipline required. Master's degree or PhD preferred.

Licenses/ Certifications:

Experience:
Minimum 2 years’ experience authoring Clinical Evaluation Reports
Proven experience of performing literature reviews, analysing data sets and communicating the outputs.
Experience working within a medical device company in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
Experience in writing scientific documents for regulatory 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 with EndNote.

 

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