Sr Associate Is Analyst - Docubridge

Amgen UK

Unknown, Unknown, United Kingdom
Lorenz docubridge expertise
Regulatory affairs collaboration
Gxp and 21 cfr part 11 compliance
Join Amgen’s mission of serving patients with serious illnesses and contribute to transforming lives through innovative medicines

Job Summary

  • Join Amgen’s mission of serving patients with serious illnesses and contribute to transforming lives through innovative medicines.
  • Play a key role in the implementation and lifecycle management of structured regulatory submission solutions, with a main focus on Lorenz DocuBridge.
  • Amgen offers a collaborative, innovative, and science-based culture with competitive benefits and support for professional and personal growth.

Matching Summary

Join Amgen’s mission of serving patients with serious illnesses and contribute to transforming lives through innovative medicines.

Skills & Requirements

Must-have

  • Lorenz DocuBridge expertise
  • Regulatory Affairs collaboration
  • GXP and 21 CFR Part 11 compliance
  • Veeva RIM knowledge
  • Agile methodology adaptability

Nice-to-have

  • Python, JavaScript programming
  • ETL Tools experience
  • API integrations (MuleSoft)
  • SQL query proficiency
  • Reporting tools (Tableau, Power BI)

Key Requirements

  • Master's degree / Bachelor's degree and 5 to 9 years of relevant experience
  • Deep understanding of pharma industry regulations (FDA, EUCTR)
  • Experience managing technology initiatives and teams
  • Experience applying SAFe and ITIL methodologies
  • Veeva Vault Platform Administrator or Equivalent Vault Certification (Mandatory)
  • SAFe for Teams (Preferred)

Work Rights

Not specified

Tailored Resume

Cover Letter