Senior Medical Content Specialist

7 days ago

vadodara, India beBeeMedicalContentCreator Full time

Medical Content Creator Job DescriptionWe are seeking a detail-oriented Medical Content Creator to join our scientific operations team supporting medical device projects.This full-time, site-based role involves creating, updating, and managing regulatory and clinical documents including Clinical Evaluation Reports, Summary of Safety and Clinical Performance Reports, State of the Art Reviews, and Systematic Literature Reviews within assigned therapeutic areas.Create and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines.Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis.Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices.Compare device safety and performance against the state of the art and investigate unexpected outcomes.Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documents.Follow all company procedures, regulatory guidelines, and health, safety, and environmental practices.Collaborate with cross-functional teams, including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.The ideal candidate will have a BA/BS/BNS degree, at least 3 years' experience in medical writing or related roles, and knowledge of CER regulatory requirements, evidence generation, and literature reviews. Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.The ideal candidate will possess the following skills and qualifications:Bachelor's degree in a relevant field.At least 3 years of experience in medical writing or a related field.Knowledge of CER regulatory requirements, evidence generation, and literature reviews.Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting.This is a full-time, site-based role that offers a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.The selected candidate will be responsible for creating high-quality content that meets regulatory requirements and supports business objectives. They will work closely with cross-functional teams to ensure seamless collaboration and effective communication.],

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