Expert Regulatory Document Specialist
3 days ago
About UsOur organization is dedicated to creating top-quality medical devices. We are currently seeking a skilled Medical Writer to join our team on a 12-month fixed-term contract.This full-time position offers the opportunity to work in a collaborative environment, supporting medical device projects. As a Medical Writer, you will create, update, and manage various regulatory and clinical documents.We require strong writing skills, attention to detail, and the ability to summarize complex data. Experience with medical writing or related fields is necessary for this role.Key ResponsibilitiesWrite and update Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) according to applicable regulations and guidelines.Participate in 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 the state of the art and investigate unexpected outcomes.Utilize software systems like Microsoft Office, EndNote, Distiller, Wrike, and AI tools to create required documents.Education & Experience RequirementsTo be successful in this role, you should have:Bachelor's degree in a relevant field (BA, BS, or BSN); advanced degree preferred.A minimum of 3 years' experience in medical writing or related roles.Knowledge of CER regulatory requirements, evidence generation, and literature reviews.Additional Qualifications/DesirableWe welcome candidates with a background in life sciences and experience in the medical device industry.
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