Senior Clinical Evaluation Medical Writer

Responsibilities may include the following and other duties may be assigned:

• Independently creates and maintains 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 in accordance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance documents and applicable Medtronic procedures and templates.
• 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).
• Reports instances of complaints/adverse events from literature to GCH.
• Create responses for audit/submission queries.
• Maintains database of peer-reviewed literature.
• Develop state of the art on product family for its intended purpose.
• Review/approve other documentation for device development.
• 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.

Required Knowledge and Experience:

• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• May have broad knowledge of project management.
• Requires a Baccalaureate degree and total 8 years of experience with minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.