Senior Medical Writer

ICON plc

Tokyo, Japan
Not specified; competitive within country; various...
Hybrid
3-5 years medical writing experience
Advanced degree in life sciences or pharmacy
Proficiency in ich-gcp and fda/ema regulations
ICON plc is seeking a Senior Medical Writer to lead the development of medical writing strategies for clinical research projects in Tokyo and Osaka

Job Summary

  • ICON plc is seeking a Senior Medical Writer to lead the development of medical writing strategies for clinical research projects in Tokyo and Osaka.
  • The role involves preparing and editing critical clinical documents such as protocols, CSRs, and IBs while ensuring compliance with global regulatory guidelines.
  • Candidates will benefit from a competitive salary, comprehensive health insurance, retirement planning, and a flexible work environment supporting work-life balance.

Matching Summary

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

Salary

Not specified; Competitive within country; Various annual leave and health insurance offerings

Skills & Requirements

Must-have

  • 3-5 years medical writing experience
  • Advanced degree in Life Sciences or Pharmacy
  • Proficiency in ICH-GCP and FDA/EMA regulations
  • Experience with CTD document preparation
  • Business level English proficiency

Nice-to-have

  • Mentoring and coaching junior staff
  • Cross-functional collaboration skills
  • Strategic input on clinical development
  • Fast-paced deadline management

Key Requirements

  • Minimum 3-5 years in pharmaceutical or CRO industry
  • University degree in Medicine, Pharmacy, or Life Sciences
  • Experience with regulatory agency interactions
  • Knowledge of protocol design through approval process
  • Japanese language skills not explicitly required but English is mandatory

Work Rights

Not specified

Tailored Resume

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