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Principal Medical Writer

Chicago, IL

Posted: 11/07/2019 Employment Type: Direct Hire Job Category: Clinical: Medical Writing Job Number: 2363

The Principal Clinical Regulatory 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. This position reports to the AD, Regulatory Operations.

Essential Job Functions:
  • Responsible for writing, formatting, and managing clinical regulatory documents including but not limited to Investigator Brochures, Clinical Study Reports, IND applications, Briefing Packages, and CTD Clinical summary documents.
  • Provides project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
  • Ensure adherence to GCP, ICH guidelines, SOPs, and internal templates.
  • Closely interacts with statistics and programming departments, including participation in the 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.
  • Supports team timelines and goals as outlined by the Medical Writing Team Lead.
  • 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, etc.).

Requirements / Qualifications:
  • 5-10 years of clinical regulatory medical writing experience (pharmaceutical/biotech company or CRO) required
  • Has acted as the lead writer on more than 5 projects for at least 3 of the following deliverables: Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, INDs, NDAs required
  • Degree in life sciences or related field is 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 required
  • 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

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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