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Medical Document Specialist

2 weeks ago

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Medical Writer RoleWe are seeking a detail-oriented Medical Writer to join our dynamic scientific operations team. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension.Create, update, and manage regulatory and clinical documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (SLRs) within assigned therapeutic areas.Participate in core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis.Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices.Compare device safety and performance against state of the art and investigate unexpected outcomes.Utilize software systems to create required documents and follow company procedures, regulatory guidelines, and health, safety, and environmental practices.Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.Requirements:Bachelor's degree or higher in life sciences or related field.Minimum 3 years' experience in medical writing or related roles.Experience in medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred.Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.This is an exciting opportunity to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative environment.