Senior Medical Writer

ICON plc

Tokyo, Japan
Not specified; competitive within each country; va...
Fully remote
Advanced degree in life sciences or related field
3-5 years experience in pharmaceutical or cro industry
Proficiency in interpreting complex clinical trial data
ICON is seeking a Senior Medical Writer to lead the development and execution of medical writing strategies for clinical research projects

Job Summary

  • ICON is seeking a Senior Medical Writer to lead the development and execution of medical writing strategies for clinical research projects.
  • The role involves preparing and editing critical documents such as clinical study protocols, reports, and regulatory submissions while ensuring compliance with global guidelines.
  • Candidates will benefit from a competitive salary, diverse health insurance offerings, and a culture focused on inclusion and work-life balance.

Matching Summary

ICON is seeking a Senior Medical Writer to lead the development and execution of medical writing strategies for clinical research projects.

Salary

Not specified; Competitive within each country; Various annual leave entitlements; Health insurance; Retirement planning; Global Employee Assistance Programme

Skills & Requirements

Must-have

  • Advanced degree in Life Sciences or related field
  • 3-5 years experience in pharmaceutical or CRO industry
  • Proficiency in interpreting complex clinical trial data
  • Strong understanding of ICH-GCP, FDA, and EMA regulations
  • Business level English proficiency for reading, writing, and speaking

Nice-to-have

  • Experience with CTD document preparation
  • Ability to mentor and coach junior medical writers
  • Strategic input on clinical development program design
  • Collaboration with cross-functional teams including biostatistics

Key Requirements

  • Minimum 3-5 years of medical writing experience
  • University degree in Medicine, Pharmacy, or Life Sciences
  • Experience with major regulatory authority submissions
  • Knowledge of protocol design through approval process
  • Business-level English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter