Senior Clinical Document Specialist

3 days ago

Gandhinagar, India beBeeRegulatory Full time

Medical Writer Job OpportunityWe are seeking a detail-oriented professional to join our scientific operations team in the medical device sector.About the Role:This is a full-time, site-based position on a 12-month fixed-term contract with the potential for extension. The Medical Writer will 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 (SLRs) within their assigned therapeutic area.Main Responsibilities:Write and update CERs, SSCPs, SOAs, and SLRs 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.Communicate business-related issues or opportunities to management effectively.Requirements:Bachelor's degree in a relevant field required; advanced degree preferred.Minimum of 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.Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.Strong oral communication, presentation, project management, and prioritization skills.Additional Qualifications/Desirable:Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) 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.This is an exciting opportunity to contribute to regulatory and scientific documentation while working in a collaborative environment.

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