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Medical Writer in Chicago, IL at Genesys Talent LLC

Date Posted: 11/16/2018

Job Snapshot

Job Description

Our client is experiencing tremendous growth and is looking for a Medical Writer to join our Regulatory team in Chicago, Illinois. The Medical Writer is responsible for researching, writing, and editing clinical documents and summarizing data from clinical studies for submission to regulatory authorities and/or for publication or presentation.

Duties and Responsibilities

  • Prepare Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA), and other documents to support product development.
  • Serves as principal medical writer and leads process for team production of clinical protocols, clinical study reports, investigator brochures, and elements of regulatory filings.
  • Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
  • Closely interacts with statistics and programming departments, including participation in development of statistical analysis plans and design of statistical outputs.
  • Organizes, conducts, and leads document development meetings and other meetings as necessary.
  • Manages processes and provides content guidance for contract medical writing support on an individual project basis.
  • Contributes to the development of formats and guidelines for clinical documentation.
  • Remains informed of the latest professional, technological, and regulatory developments in medical writing and in relevant therapeutic areas
  • Participates in study team and strategy meetings
  • May periodically interact with various levels of management and CROs
  • May assist in the development of publications (abstracts, posters, manuscripts)

Qualifications

  • A minimum of 7 years of medical writing experience (pharmaceutical/biotech company or CRO)
  • Degree in life sciences or related field preferred
  • Excellent verbal and written communication skills and an ability to lead discussions and resolve issues related to document development
  • Mastery of Good Documentation Practices
  • Attention to detail and ability to generate clean, consistent, coherent documents
  • Solid understanding of the drug development process, clinical study conduct and data collection, and interactions essential for the production of regulatory submissions
  • Familiarity with all phases of clinical research and ability to learn new medical concepts quickly