Chief Medical Documentation Specialist

6 days ago

bhavnagar, India beBeeMedicalWriter Full time

We are seeking a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector.About the Role:This is an exciting opportunity to work in a collaborative, cross-functional environment where you will create, update, and manage a range of regulatory and clinical documents.As a Medical Writer, you will be responsible for writing and updating Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) within your assigned therapeutic area.You will participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis. You will also summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices.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 reviewsSummarize clinical, non-clinical, and regulatory dataCompare device safety and performance against the state of the artUtilize various software systems to create required documentsFollow company procedures, regulatory guidelines, and health, safety, and environmental practicesEducation & Experience Requirements:Bachelor's degree in life sciences or a related field is required; advanced degree preferred. Minimum of 3 years' experience in medical writing or related roles.Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews is preferred.Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.

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