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Job Details


Medical Writer / Contract
Fort Washington, PA  Posted: 5/13/2019

Details:

Our client is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. 
 
Medical Writer - Long term Contract - Work Remote 
 
Immediate Need for Medical Writers to plan and execute 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.
 
Requirements:
  • 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 Pharmaceutica
  • and/or Medical Device companies
  • Has published, peer-reviewed studies/literature in scientific and/or medical journals preferred
  • Pharmacoepidemiology and Biostatistics knowledge preferred

Job ID#:

6367

 



 

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