Job Title: Clinical Documentation Specialist
This role is responsible for providing support to assigned clinical projects. These projects ensure product conformity of medical devices to EU regulations.
* Prepare, write, edit and review 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 document systematic literature searches in medical databases on products, specific indications, outcomes or other topics.
* Appraise, grade, analyse and write up clinical data obtained through systematic searches to establish clinical evaluation acceptance criteria and compare subject device data to demonstrate compliance to relevant safety and performance requirements.
* Ensure documents are produced in accordance with procedures, internal and external guidelines such as ISO standards.
Key Responsibilities:
* Establish and oversee digital clinical libraries to ensure evidence is organized and maintained appropriately.
* Knowledge of clinical research of medical devices including preparing, writing, editing and reviewing clinical investigation documents.
* Client management tasks such as project scoping and proposal writing, proposal management and scheduling.
Requirements:
* Bachelor's degree or equivalent in a life science or healthcare field.
* At least 5 years of documented professional experience in a life science or healthcare field or as a medical writer.
* Excellent attention to detail and execution of critical appraisal of information.
* Fluent written and spoken English.
* Excellent verbal and written communication skills.
* Full competency and proficiency with Microsoft Office.
* Experience with document control within a quality management system is strongly desired.
Benefits:
* Opportunity to work on exciting clinical projects.
* Collaborative and dynamic work environment.
Others:
* Able to travel occasionally for client meetings.