Senior Medical Writer at ICON Strategic Solutions leading the development and execution of medical writing strategies for clinical research projects. The role involves independently producing regulatory and clinical documents, mentoring junior writers, and ensuring submission-ready deliverables across multiple therapeutic areas in a sponsor-dedicated model.
Responsibilities
Independently produce clinical study protocols, reports, and regulatory documents with guidance from senior colleagues
Analyze and interpret clinical trial data to determine optimal document composition strategies
Serve as primary contact for study teams regarding document preparation timelines and planning
Mentor and coach junior medical writers on best practices and scientific principles




Facilitate document reviews and ensure regulatory submission readiness with QC and publishing support
Requirements
~3-5 years of experience as a regulatory writer
~ Mandatory protocol writing experience in Phase II or III clinical trials
~ Bachelor's degree in relevant scientific discipline or healthcare field
~ Proficiency in interpreting clinical trial data and statistical analyses
~ Strong understanding of regulatory requirements (ICH-GCP, FDA, EMA)
~ Excellent written and interpersonal communication skills
~ Ability to collaborate effectively with cross-functional teams

📌 Senior Science/Medical Writer (España)
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📍 España