A healthcare company in Shannon, Ireland is seeking a Senior Clinical Affairs Specialist regarding medical writing activities. The successful candidate will ensure compliance with EU regulations, prepare clinical documents, and collaborate with project teams. Excellent communication skills and a background in medical writing are essential for this role, along with 5+ years of experience in a related field. #J-18808-Ljbffr
Job Title: Senior Clinical Affairs Specialist (Medical Writing) Contract Type: 9-month contract This position is responsible for providing support for assigned clinical projects. These projects ensure product conformity of medical devices to EU MDD or MDR. The Medical Writer will provide support to the functional project teams leading to sound clinical documents for new and existing products/indications. The role will predominantly involve writing clinical evaluation plans (CEPs) and reports (CERs), participating and interacting with project groups ensuring EU MDD/MDR compliance, assisting with clinical submissions to notified bodies and other regulatory bodies and other departmental projects as assigned. The role may also involve working with clinical investigation project planning teams externally to assist in writing clinical investigation documents in order to gain EU MDR conformity in the future or to generate post-market clinical follow up data. Responsibilities and Accountabilities Preparing, writing, editing, and reviewing Instructions for use (IFUs), Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Plans (PMCFPs), Post Market Clinical Follow-up Reports (PMCFRs) and Summary of Safety and Clinical performance (SSCPs) Design, conduct and documentation of systematic literature searches in medical databases on products, specific indications, outcomes, or other topics. Appraisal, grading, analysis and write up of all clinical data obtained through the systematic searches to establish clinical evaluation acceptance criteria and quantitatively compare subject device data to demonstrate compliance to relevant general safety and performance requirements (GSPRs). Knowledge of risk management processes for medical devices (such as ISO 14971) to provide clinical input and review to risk management personnel. Knowledge and understanding of proposed and current global medical device regulations and guidance and the ability to relay the impact of such regulations and guidance internally and with our clients. Ensuring documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4, (EU) MDR 2017/745, relevant MDCGs, ISO standards). Appraising, analysing and summarizing clinicaldata and preparing reports, figures, and scientific meeting presentations. Establishing and overseeing digital clinical libraries, to ensure evidence is organized and maintained appropriately. Knowledge of clinical research of medical devices (Good clinical practice principles: ISO 14155 and relevant MDCG guidance) including preparing, writing, editing and reviewing clinical investigation documents such as Clinical investigation plans (CIPs), Investigator Brochure (IB), case report form (CRFs) Client management tasks such as; project scoping and proposal writing, proposal management and scheduling, leading weekly progress calls with clients. Qualifications and Education Requirements At minimum a bachelor's degree or equivalent in medical-related field or life science/healthcare field. Post-graduate degree preferred. At least 5 years of documented professional experience in a life science or healthcare field or as a medical writer with good clinical/scientific writing skills. Specific Role Requirements and Skills Medical writing (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal), excellent attention to detail and execution of critical appraisal of information Fluent written and spoken English. Excellent verbal and written communication. Full competency and proficiency with Microsoft Word, Excel, SharePoint, Teams and Outlook. Experience with document control within a quality management system is strongly desired. Excellent interpersonal and customer service skills. Knowledge or experience with the following Research methodology (including clinical investigation design and biostatistics); Information management (e.g. scientific background or librarianship qualification; experience with relevant databases such as Cochrane library and PubMed Medline); Regulatory requirements for medical devices in the EU #J-18808-Ljbffr
Job Title:Senior Clinical Affairs Specialist (Medical Writing) Contract Type:9-month contract This position is responsible for providing support for assigned clinical projects. These projects ensure product conformity of medical devices to EU MDD or MDR. The Medical Writer will provide support to the functional project teams leading to sound clinical documents for new and existing products/indications. The role will predominantly involve writing clinical evaluation plans (CEPs) and reports (CERs), participating and interacting with project groups ensuring EU MDD/MDR compliance, assisting with clinical submissions to notified bodies and other regulatory bodies and other departmental projects as assigned. The role may also involve working with clinical investigation project planning teams externally to assist in writing clinical investigation documents in order to gain EU MDR conformity in the future or to generate post-market clinical follow up data. Responsibilities and Accountabilities: Preparing, writing, editing, and reviewing Instructions for use (IFUs), Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Plans (PMCFPs), Post Market Clinical Follow-up Reports (PMCFRs) and Summary of Safety and Clinical performance (SSCPs) Design, conduct and documentation of systematic literature searches in medical databases on products, specific indications, outcomes, or other topics. Appraisal, grading, analysis and write up of all clinical data obtained through the systematic searches to establish clinical evaluation acceptance criteria and quantitatively compare subject device data to demonstrate compliance to relevant general safety and performance requirements (GSPRs). Knowledge of risk management processes for medical devices (such as ISO 14971) to provide clinical input and review to risk management personnel. Knowledge and understanding of proposed and current global medical device regulations and guidance and the ability to relay the impact of such regulations and guidance internally and with our clients. Ensuring documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4, (EU) MDR 2017/745, relevant MDCGs, ISO standards). Appraising, analysing and summarizing clinicaldata and preparing reports, figures, and scientific meeting presentations. Establishing and overseeing digital clinical libraries, to ensure evidence is organized and maintained appropriately. Knowledge of clinical research of medical devices (Good clinical practice principles: ISO 14155 and relevant MDCG guidance) including preparing, writing, editing and reviewing clinical investigation documents such as Clinical investigation plans (CIPs), Investigator Brochure (IB), case report form (CRFs) Client management tasks such as; project scoping and proposal writing, proposal management and scheduling, leading weekly progress calls with clients. Qualifications and Education Requirements At minimum a bachelor's degree or equivalent in medical-related field or life science/healthcare field. Post-graduate degree preferred. At least 5 years of documented professional experience in a life science or healthcare field or as a medical writer with good clinical/scientific writing skills. Specific Role Requirements and Skills: Medical writing (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal),excellent attention to detail and execution of critical appraisal of information Fluent written and spoken English. Excellent verbal and written communication. Full competency and proficiency with Microsoft Word, Excel, SharePoint, Teams and Outlook. Experience with document control within a quality management system is strongly desired. Excellent interpersonal and customer service skills. Knowledge or experience with the following: Research methodology (including clinical investigation design and biostatistics); Information management (e.g. scientific background or librarianship qualification; experience with relevant databases such as Cochrane library and PubMed Medline); Regulatory requirements for medical devices in the EU
