Senior Scientific Content Specialist

7 days ago

davangere, India beBeeRegulatory Full time

Medical WriterThe Opportunity:We are seeking a skilled medical writer to support the creation of regulatory and clinical documents for medical devices. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension.About the Role:As a medical writer, you will be responsible for creating, updating, and managing a range of 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 AffairsCommunicate business-related issues or opportunities to management effectivelyEducation & Experience Requirements:BA, BS, or BSN required; advanced degree preferredMinimum of 3 years' experience in medical writing or related rolesExperience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferredFamiliarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plusAdditional Qualifications/Desirable:Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) is welcomedExperience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage

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