The medical writer is primarily responsible for preparing Clinical Evaluation Reports (CERs) and associated documents for regulatory submissions and Post-market Surveillance for analysis of existing product clinical performance, while working in a cross-functional team. This includes conducting searches of peer-reviewed publications, risk management files and post market quality tabulations to compile relevant data. Report preparation involves summarizing data and writing risk versus benefit analyses for products in a format defined to satisfy regulatory requirements. The medical writer may also prepare technical documents, study protocols, investigational plans, manuscripts for publication, or white papers. The scope includes AirLife anesthesia and respiratory medical devices.
Principal Duties and Responsibilities:
Skills
Education/Experience Requirements:
Experience:
Travel: up to 20%