Description

The Medical Writer plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects.

Requirements

• Participates in the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area
• Prepares, writes, and edits creditable systematic literature reviews through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices
• Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes
• Performs data extraction of included studies into a data collection tool (e.g. Microsoft Excel, Distiller)
• Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS)
• Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports
• Organizes clinical data from literature into references, graphics, tables, and data listings
• Critically synthesizes clinical data being considered for presentation in the final report
• Performs scientific writing of the synthesized literature using templates
• Interprets and summarizes complex results from the medical and scientific literature and present them in clear, concise, and scientifically accurate manner to various end users requiring the ability understand and interpret statistical results of clinical studies
• Presents the results of systematic literature reviews at internal meetings