Medical Documentation Specialist

1 week ago

india beBeeRegulatory Full time

Job Title: Medical WriterLocations: India, Mexico, Brazil Department: Scientific OperationsWe are seeking a skilled medical writer to join our dynamic scientific operations team.The successful candidate will be responsible for creating, updating, and managing 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 (LRRs) within their assigned therapeutic area.Key Responsibilities:Write and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelinesParticipate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesisSummarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devicesCompare device safety and performance against the state of the art and investigate unexpected outcomesUtilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documentsFollow all company procedures, regulatory guidelines, and health, safety, and environmental practicesCollaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory AffairsEducation & Experience Requirements:• Bachelor's degree in a relevant field or higher• Minimum of 3 years' experience in medical writing or related roles• Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plusAdditional Qualifications/Desirable:• Background in life sciences welcomed• Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantageThis is an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative environment.

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