Global Regulatory Writing Manager

Amgen UK

United Kingdom
Author regulatory submission documents
Conduct formal review and approval
Manage regulatory writing activities
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

  • Author regulatory submission documents
  • Conduct formal review and approval
  • Manage regulatory writing activities
  • Serve as functional area lead
  • Knowledge of ICH and GCP guidance

Nice-to-have

  • Maintain key business relationships
  • Train and mentor junior writers
  • Participate in departmental initiatives
  • Keep abreast of relevant information

Key Requirements

  • Doctorate degree OR Master’s degree and 4 to 6 years of directly related experience
  • Bachelor’s degree and 6 to 8 years of directly related experience
  • Diploma and 10 to 12 years of directly related experience
  • Proficiency with word processing and Microsoft Office Programs
  • Significant knowledge of scientific/technical writing
  • Ability to understand and follow complex SOP’s
  • Substantial knowledge of ICH and GCP guidance’s

Work Rights

Not specified

Tailored Resume

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