We have a unique opportunity with a global medical monitor manufacturing company, working in clinical compliance.
Our client is seeking a Clinical Research Medical Writer CER in the Northeast!
Our client is a global leader in the development, manufacture, and distribution of medical devices. This position is a key role in the compliance sector of the organization. The company specializes in developing innovative solutions that simplify and improve the lives of their target patients by combining advanced technology with user-friendly functionality.
The candidate will play an integral role in the implementation and gap assessment mitigation for clinical requirements related to the new EU Medical Device Regulation (MDR) and IVD Regulation (IVDR) compliance regulation. The candidate will also participate in ensuring maintenance of these records are kept up to date as expected by regulatory agencies.
- Provide relevant information to IVDR/MDR team. This includes but not limited to literature search, database mining, collating reports.
- Assess potential clinical study gaps existing against IVDR/MDR for the whole company portfolio.
- Put mitigations in place to secure compliance, this may include clinical design development, literature search, etc.
- Execute mitigation plan with proper functions. This may include clinical study execution.
- Maintain Summary of Safety and Performance, Performance Evaluation Reports and Clinical Evaluation Reports and other relevant clinical documents and files for all regulatory agencies.
- Master’s or Doctoral degree in Healthcare Science or related discipline, with a minimum of 3 years’ experience in clinical study/regulatory/research environment.
- At least 2 years of Medical Device medical writing experience (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal).
- Experience of writing and reviewing CERs is mandatory.
- Experience in the Medical Device/Diagnostics and/or Pharmaceutical Industry, preferably in the area of Diabetes and blood glucose measurement. Understand diagnosis and management of diabetes, possess knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty).
- Possess knowledge of research methodology (including clinical investigation design and biostatistics).
- Proficient in information management (e.g. scientific background or librarianship qualification; experience with relevant databases such as Embase and Medline).
- Understand regulatory environment and requirement.
- Experienced in conducting clinical studies.
- Excellent personnel and project management, interpersonal, and organizational skills and business acumen are essential.
- Be able to gain an understanding of the device technology and its application.
Qualified Candidates, Please Send us your CV
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