Career Opportunity for Detail-Oriented Professional

1 week ago

ghaziabad, India beBeeMedicalWriter Full time

Job Title: Medical WriterWe are seeking a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector.About the Role:This is an exciting opportunity to work in a collaborative, cross-functional environment supporting medical device projects.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 all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis.Key Responsibilities:Key responsibilities include writing and updating documents, participating in systematic literature reviews, summarizing clinical, non-clinical, and regulatory data, and utilizing various software systems to create required documents.We follow all company procedures, regulatory guidelines, and health, safety, and environmental practices. Collaboration with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs is essential.Requirements:To be successful in this role, you will need:Bachelor's degree or higher in life sciences or related field.A 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.Additional Qualifications:Candidates with background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) and experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations are welcomed.

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