Scientific Document Specialist

2 weeks ago


tiruppur, India beBeeMedicalWriter Full time

Medical Writer RoleOur organization is seeking a skilled Medical Writer to join our team. As a Medical Writer, you will play a crucial role in creating and updating regulatory and clinical documents for medical device projects.Key Responsibilities:Write and update Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs)Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesisSummarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devicesCompare device safety and performance against the state of the art and investigate unexpected outcomesRequirements:Bachelor's degree in Life Sciences or related field required; advanced degree preferredMinimum 3 years' experience in medical writing or related rolesExperience in medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferredAdditional Qualifications:Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) welcomedExperience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantageThis is an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector.



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