Scientific Documentation Specialist

6 days ago

bikaner, India beBeeMedical Full time

Medical Writer Job DescriptionWe are seeking a skilled Medical Writer to join our scientific operations team. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension.The Medical Writer will create, update, and manage 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.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 outcomesThis role requires strong oral communication, presentation, project management, and prioritization skills. A background in life sciences or experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations are considered advantages.This 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, cross-functional environment.Key RequirementsBA, BS, or BSN degree 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 preferredBenefitsThis role offers a unique opportunity to work on challenging projects and develop your skills in a fast-paced environment. You will be part of a dynamic team that values collaboration and open communication.If you are a motivated and detail-oriented individual with a passion for medical writing, we encourage you to apply for this exciting opportunity.

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