Document Specialist

6 days ago

anand, India beBeeMedical Full time

Medical Writer RoleA Medical Writer will create, update, and manage regulatory and clinical documents. This includes Clinical Evaluation Reports, Summary of Safety and Clinical Performance Reports, State of the Art Reviews, and Systematic Literature Reviews within their assigned therapeutic area.Responsibilities:Create and revise CERs, SSCPs, SOAs, and LRRs in compliance with relevant regulations and guidelines.Participate in systematic literature reviews, including search, screening, data extraction, analysis, and synthesis.Analyze clinical, non-clinical, and regulatory data to evaluate risk/benefit analyses for medical devices.Evaluate device safety and performance against the state of the art and investigate unexpected outcomes.Utilize software systems, such as Microsoft Office, EndNote, Distiller, Wrike, and AI tools, to produce required documents.Adhere to 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.Required Skills and Qualifications:Strong writing and editing skills.Ability to analyze complex data and information.Familiarity with regulatory requirements and guidelines.Excellent communication and collaboration skills.Proficiency in software systems, such as Microsoft Office, EndNote, Distiller, Wrike, and AI tools.Benefits:This role offers a dynamic work environment and opportunities for professional growth and development.About this Role:This is an exciting opportunity to join our team as a Medical Writer and contribute to the creation of high-quality clinical documents.

  • Documentation Specialist

    6 days ago

    anand, India beBeeTechnical Full time

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    anand, India beBeeDocument Full time

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    anand, India beBeeTechnicalWriting Full time

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    anand, India beBeeRegulatory Full time

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    Anand, India Whatjobs IN C2 Full time

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    anand, India beBeeVim Full time

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    anand, India beBeeStructural Full time

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    anand, India beBeeCompliance Full time

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