CER Writer (Remote, Part-time - 300 hrs total)
- This individual should have 2- 5 years or close to that experience authoring/executing Clinical Evaluation Reports, Clinical Evaluation Plans, and PMCF Plan or Reports.
- Must have MDR experience with Clinical Evaluation Report writing experience.
- High degree of project management, excellent communication, and initiative.
Education Required: Bachelor's degree required; Strongly preferred to have master's or PhD degree(s) in biomedical sciences or technical disciplines
Years’ Experience Required: Minimum of 4 years medical or clinical writing experience which includes (2 years scientific writing for EU MDR, this includes Clinical Evaluation Reports (CERs) Clinical Evaluation Plans (CEPs), PMCF Plans, and or reports).
Description:
This role predominantly focuses on writing, editing, and maintaining Clinical Evaluation Plans and Reports (CEP, CER), and Post Market Follow-up (PMCF) Plans and Report, and Periodic Safety Update Reports (PSUR). and responses to Notified Bodies.
Duties:
- Conducts comprehensive literature searches and performs critical evaluation of clinical evidence (including risk/benefit, State of the Art, etc.) for generation of new/maintenance of existing Clinical Evaluation Reports (CERs) in compliance with the EU Medical Device Regulation, Australia Dept of Health Guidelines, and other geographic regulations as required, or to support product development, risk analysis, regulatory submissions, or due diligence efforts.
- Assesses on an ongoing basis the quality, scientific validity, and audit-readiness of CERs.
- Supports internal and regulatory body audits of clinical materials, including remediation of content as required.
- Analyzes clinical evidence of all kinds (e.g., public, proprietary, published, unpublished) from all sources (e.g., journals, internal documents, regulatory submissions) to assist project proposals and departmental strategies, understanding the levels of evidence required to achieve Regulatory, Marketing, and other departmental goals
- Review and summarize scientific literature.
- Reports instances of complaints/adverse events from literature to GCH.
- Create responses for audit/submission queries.
- Maintains database of peer-reviewed literature.
- Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
- Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
- Develop state of the art on product family for its intended purpose.
- Create & maintain plans and reports for regulatory authorities.
- Review/approve other documentation for device development.
- Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
