Job Description

The Clinical Evaluation Specialist supports the development of clinical evaluation documents e.g. CEP CER PMCFP PMCFR and SSCP throughout the product development and lifecycle. Experience in medical or scientific writing critical literature review and data analysis and/or quality engineering/risk management and strong written and verbal communication skills are needed. This support role will support a lead author through the clinical evaluation process by writing documents reviewing literature and other tasks under the direction of the lead author.

• Supports the clinical evaluation process by writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), Post Market Clinical Follow Up Reports (PMCFR) and Summary of Safety and Clinical Performance [SSCP] for medical devices. 
• Identifies, evaluates, appraises, analyzes, summarizes and synthesize clinical evidence including data from sources such as preclinical studies, clinical investigations, literature, and other post-market surveillance sources. Analyzes results in preparation for product applications and submissions.  
• Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Review and summarize scientific literature (e.g. screens articles against inclusion/exclusion criteria, analyzes and appraises the quality, suitability and relevance of the included studies, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports).
• Reviews IFUs, Risk Management files and other cross-functional documents to ensure alignment of risk information.
• Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
• Clearly and timely communicates timelines, required inputs for projects, project risks, etc. with cross-functional stakeholders.

• Requires a Baccalaureate degree with minimum 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
• Experience in medical or scientific writing critical literature review and data analysis and/or quality engineering/risk management and strong written and verbal communication skills are needed.

Job Tags

Similar Jobs