Global Regulatory Writing – Manager, Japan

Amgen UK

Tokyo, Japan
Regulatory submission document authoring
Knowledge of ich and gcp guidelines
Strong written and oral communication skills
The role involves authoring and gaining approval of scientific and regulatory submission documents

Job Summary

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

Matching Summary

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

Skills & Requirements

Must-have

  • Regulatory submission document authoring
  • Knowledge of ICH and GCP guidelines
  • Strong written and oral communication skills

Nice-to-have

  • Leadership in team environment
  • Experience with document management systems
  • Mentoring junior writers

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