HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

WHAT YOU WILL DO

In this vital role you will drive the process documentation transformation for end-to-end clinical trial execution by developing and implementing a modern framework that aligns with regulatory standards and industry best practices.
This is a high-impact role critical to ensuring regulatory inspection readiness and effective adoption of new ways of working across the organization.

KEY RESPONSIBILITIES:

• Collaborate cross-functionally with stakeholders across Clinical Development, Clinical Operations, Quality, Transformation, and Training/Knowledge Management teams as well as oversee external partners to ensure SOPs, training materials, and guidance documents are optimized for usability and compliance
• Collaborate with clinical experts to identify operational needs and shape documentation strategies
• Oversee external vendors delivering technical writing, process mapping, and change management support, ensuring outputs are aligned with strategic goals and delivered on time
• Drive change impact analysis and mapping by balancing current vs. future-state taxonomies for new and transitioning trials
• Support operational excellence through documentation that drives understanding and behavior change
• Drive “blank sheet” and holistic thinking to design user-friendly, future-state documentation and processes that are user-centric, intuitive, and connected across functions
• Sustain process documentation effectiveness through lifecycle management, reviews, and performance metrics