Sr Medical Writer Job at ICON, Canada

  • ICON
  • Canada

Job Description

Senior Medical Writer position at ICON Strategic Solutions in a sponsor-dedicated model. Lead development of medical writing strategies for clinical research projects, managing regulatory documents and clinical communications while mentoring junior writers.

Responsibilities

  • Lead preparation, review, and editing of clinical protocols, study reports, investigator brochures, and regulatory submissions
  • Collaborate with clinical, biostatistics, regulatory, and medical affairs teams to analyze trial data and summarize findings
  • Provide strategic input on clinical development program planning and study design interpretation
  • Develop publication plans and prepare abstracts, posters, and manuscripts for scientific conferences and journals
  • Mentor junior medical writers on best practices, writing techniques, and scientific principles

Requirements

  • Bachelor's degree in relevant scientific or healthcare discipline
  • Proficiency in interpreting clinical trial data and statistical analyses with strong writing skills
  • Knowledge of regulatory requirements (ICH-GCP, FDA, EMA) and submission processes
  • Ability to manage multiple projects simultaneously in deadline-driven environments
  • Excellent interpersonal and cross-functional collaboration skills

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