Global Regulatory Writing Manager

Amgen Inc

Regulatory submission documents authoring
Clinical development process knowledge
Ich and gcp guidance understanding
In this vital role you will maintain key business relationships with appropriate cross-functional product team members

Job Summary

  • In this vital role you will maintain key business relationships with appropriate cross-functional product team members.
  • Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents.
  • In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Matching Summary

In this vital role you will maintain key business relationships with appropriate cross-functional product team members.

Skills & Requirements

Must-have

  • Regulatory submission documents authoring
  • Clinical development process knowledge
  • ICH and GCP guidance understanding
  • Scientific/technical writing and editing proficiency

Nice-to-have

  • Leadership in team environment
  • Negotiation and persuasion skills
  • Drive and perseverance to achieve results

Key Requirements

  • Doctorate degree OR Master’s degree and 4-6 years experience OR Bachelor’s degree and 6-8 years experience OR Diploma and 10-12 years experience
  • Proficiency with word processing and Microsoft Office Programs
  • Ability to understand and follow complex standard operating procedures (SOP’s)

Work Rights

Not specified

Tailored Resume

Cover Letter