Global Regulatory Writing – Manager, Japan

Amgen

Tokyo, Japan
Regulatory submission document authoring
Strong written and oral communication skills
Experience in clinical development process
The role involves authoring and gaining approval of regulatory submission documents

Job Summary

  • The role involves authoring and gaining approval of regulatory submission documents.
  • You will maintain key business relationships with cross-functional product team members.
  • This position may include training and mentoring junior regulatory writers.

Matching Summary

The role involves authoring and gaining approval of regulatory submission documents.

Skills & Requirements

Must-have

  • Regulatory submission document authoring
  • Strong written and oral communication skills
  • Experience in clinical development process

Nice-to-have

  • Leadership in team environment
  • Understanding of ICH and GCP guidelines
  • Advanced knowledge of document management systems

Key Requirements

  • Doctorate or Master's degree
  • 5+ years experience in medical writing
  • Upper-intermediate level business English

Work Rights

Not specified

Tailored Resume

Cover Letter