Scientific Documentation Specialist

1 week ago

Jamnagar, India beBeeRegulatory Full time

Medical Writer RoleAbout the OpportunityWe are seeking a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector.This is an exciting opportunity for a skilled Medical Writer to join a dynamic scientific operations team supporting medical device projects.The successful candidate 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).The ideal candidate will have excellent writing and analytical skills, with experience in medical writing or related roles. Knowledge of CER regulatory requirements, evidence generation, and literature reviews is preferred.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 documentsRequirements: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 preferredBenefits:This role offers the opportunity to work in a collaborative, cross-functional environment and contribute to regulatory and scientific documentation within the medical device sector.

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