Senior Clinical Document Specialist

2 weeks ago

surat, India beBeeMedicalWriter Full time

Medical Writer – Contract PositionAbout the Role:We are seeking a detail-oriented Medical Writer to contribute to regulatory and scientific documentation within the medical device sector.This is an exciting opportunity to work in a collaborative, cross-functional environment and be part of our dynamic scientific operations team.Key Responsibilities:• Create, update, and manage 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)• Write and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines• Participate in 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• Utilize various software systems to create required documentsEducation & Experience Requirements:• Bachelor's degree in life sciences or related field; advanced degree preferred• Minimum 3 years' experience in medical writing or related roles• Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting a plusBenefits:• Opportunity to work on a range of regulatory and clinical documents• Collaborative, cross-functional environment• Potential for professional growth and development

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