Senior Associate IS Analyst - DocuBridge - Remote

Overview

The Senior Associate IS Analyst - DocuBridge will play a key role in the implementation and lifecycle management of structured regulatory submission solutions, focusing on Lorenz DocuBridge, to support Amgen’s mission of serving patients.

In Short

• Implement and manage structured regulatory submission solutions.
• Collaborate with internal and vendor partners for compliant submissions.
• Assist in validation testing and user experience optimization.
• Support project plans, timelines, and resource allocation.
• Oversee validation and compliance readiness.
• Monitor system performance and resolve issues.
• Develop training materials and conduct user training.
• Lead continuous improvement initiatives for system usability.
• Act as SME during audits and inspections.
• Use Jira and ServiceNow for project tracking.

Requirements

• Master's/Bachelor's degree with 5-9 years of relevant experience.
• Deep understanding of pharma regulations (FDA, EUCTR).
• Experience with Lorenz DocuBridge and Regulatory Veeva RIM.
• Proven technology initiative management.
• Familiarity with Agile and ITIL methodologies.
• Strong knowledge of information systems and network technologies.
• Experience with relational databases and programming languages.
• Excellent communication and collaboration skills.
• Ability to manage multiple priorities effectively.
• Professional certifications in Veeva or SAFe preferred.

Benefits

• Competitive salary and comprehensive benefits.
• Support for professional and personal growth.
• Collaborative culture focused on innovation.
• Opportunities for continuous learning.
• Inclusive environment respecting diversity.