The role of a Clinical Affairs Specialist in Medical Writing involves providing support for assigned clinical projects.
These projects ensure product conformity of medical devices to EU MDD or MDR regulations.
The Medical Writer will provide support to the functional project teams leading to sound clinical documents for new and existing products/indications.
Key Responsibilities:
* 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)
Requirements and Skills:
A minimum of 5 years documented professional experience in a life science or healthcare field or as a medical writer with good clinical/scientific writing skills is required.
Fluent written and spoken English is also essential.
Familiarity with document control within a quality management system and knowledge of risk management processes for medical devices are highly desirable.
Candidates should have excellent attention to detail and execution of critical appraisal of information.