Sr Medical Writer
ICON · Cary, NC +1 more
Medical AffairsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.