Our client has an exciting opportunity for a Medical Writer. This position can work remotely.
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 within R&D Medical Device sector. The high-level activities may include:
• 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
• 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
• Collaborates with other Medical Operation Team members including Technical Specialists and Project Managers as applicable to gather information (timelines, projects, documents)
• Adheres to timeliness for systematic literature reviews within assigned project
• Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process to identify the necessary clinical and technical information for assigned project
Demonstrates an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study design, ensures compliance with medical device regulations globally, and escalates any new or emerging risks.
• Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates.
• Conducts scientific and medical writing and/or critically edits the deliverables (e.g. protocols and reports) from medical writing staff
• M.D. or PhD educational level (Pharmacy/Life Sciences)
• Strong knowledge of Clinical and Scientific Research Methodology
• Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety)
• Excellent communication skills (writing and verbal) in English
• Work experience in R&D/Drug Development and/or Device Development in Pharmaceutical and/or Medical Device companies
• Has published, peer-reviewed studies/literature in scientific and/or medical journals preferred
• Pharmacoepidemiology and Biostatistics knowledge preferred