CER Technical Medical Writer

Job Description

As a Medical Writer in the Scientific Operations department, you will be responsible for creating, updating, and managing various regulatory and clinical documents for medical device projects. Your main role will involve writing and updating Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) in compliance with regulatory requirements and guidelines.Key Responsibilities:- Write and update CERs, SSCPs, SOAs, and LRRs while ensuring compliance with regulatory requirements and guidelines- Participate in all steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis- Summarize clinical, non-clinical, and regulatory data to conduct 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 such as Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools to create necessary documents- Adhere to 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- Effectively communicate business-related issues or opportunities to managementQualifications Required:- BA, BS, or BSN 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 plusAdditional Details:This role offers an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector. Working in a collaborative, cross-functional environment, you will play a key role in supporting medical device projects through the creation and management of essential regulatory and clinical documents. As a Medical Writer in the Scientific Operations department, you will be responsible for creating, updating, and managing various regulatory and clinical documents for medical device projects. Your main role will involve writing and updating Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) in compliance with regulatory requirements and guidelines.Key Responsibilities:- Write and update CERs, SSCPs, SOAs, and LRRs while ensuring compliance with regulatory requirements and guidelines- Participate in all steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis- Summarize clinical, non-clinical, and regulatory data to conduct 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 such as Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools to create necessary documents- Adhere to 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- Effectively communicate business-related issues or opportunities to managementQualifications Required:- BA, BS, or BSN 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 plusAdditional Details:This role offers an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector. Working in a collaborative, cross-functional environment, you will play a key role in supporting medical device projects through the creation and management of essential regulatory and clinical documents.

Keyskills :
Medical WritingRegulatory RequirementsLiterature ReviewsMicrosoft OfficeEndNoteProject ManagementClinical ResearchAdverse Event ReportingClinical DocumentsRiskBenefit AnalysisWrike