Document Specialist

1 day ago

mangalore, India beBeeMedicalWriter Full time

Job Opportunity: Medical Writer – 12-Month Fixed Term ContractWe are seeking a highly skilled and detail-oriented Medical Writer to join our dynamic team. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension.About the Role:The ideal candidate will have experience in medical writing, regulatory documentation, and clinical research. They will be responsible for creating, updating, and managing various documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (SLRs).Key Responsibilities:• Write and update CERs, SSCPs, SOAs, and SLRs 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• Compare device safety and performance against the state of the art and investigate unexpected outcomes• Utilize software systems, including Microsoft Office, EndNote, Distiller, Wrike, and AI tools, to create required documents• Follow 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• Communicate business-related issues or opportunities to management effectivelyRequired Skills and Qualifications:• Bachelor's degree in a life science discipline; advanced degree preferred• Minimum 3 years' experience in medical writing or related roles• Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred• Strong oral communication, presentation, project management, and prioritization skillsBenefits:This is an exciting opportunity to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative environment.Additional Qualifications/Desirable:• Background in life sciences welcomed• Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage• Proven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devices• Experience reviewing supporting device documentation and analyzing device performance data

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