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Sr Mgr - Technical Product Owner Regulatory AI

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Amgen

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Location:
United States , Thousand Oaks

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

166626.00 - 202396.00 USD / Year
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Job Description:

In this vital role you will support and advance the Regulatory Content Automation capability ecosystem.

Job Responsibility:

  • Serve as the Technology Process lead for regulatory content automation solutions, including structured content authoring, publishing, submission, and downstream integrations
  • Define, document, and maintain end-to-end regulatory processes, ensuring consistency, scalability, and alignment with global regulatory standards
  • Lead post-MVP stabilization efforts, continuous improvement initiatives, and future roadmap development aligned with regulatory transformation goals
  • Act as IT Application Owner for designated platforms, including lifecycle management, system decommissioning, and integration oversight
  • Drive planning, execution, and delivery across Agile / SAFe product teams, serving as a key contributor in PI planning, backlog prioritization, and dependency management
  • Translate regulatory business needs into clear business and technical requirements, partnering with engineering and architecture teams to deliver fit-for-purpose solutions
  • Apply and reuse global technology capabilities and standards to deliver differentiated, compliant platforms
  • Lead GxP and computer system validation activities, including implementation of Risk-Based Validation (RBV) strategies
  • Ensure ongoing compliance with FDA 21 CFR Part 11, GxP, and Amgen SOPs
  • Support audit and inspection readiness through ownership of validation documentation, system controls, and traceability artifacts
  • Lead technical discussions and integrations across platforms such as Veeva Vault RIM, AWS (e.g., S3), structured content tools, GenAI-enabled capabilities, and document management solutions
  • Partner with data, UX, and architecture teams to ensure solution quality, performance, and extensibility
  • Evaluate vendors and emerging technologies through proof-of-concepts and pilots, ensuring alignment with enterprise standards and user experience goals
  • Mentor and guide junior business analysts and delivery team members, promoting ownership, continuous learning, and cross-functional collaboration
  • Engage business stakeholders to set expectations, manage priorities, and ensure transparent communication
  • Support diversity, inclusion, and team engagement initiatives within the organization

Requirements:

  • Doctorate degree and 2 years of Information Systems experience
  • Master’s degree and 4 years of Information Systems experience
  • Bachelor’s degree and 6 years of Information Systems experience
  • Associate’s degree and 10 years of Information Systems experience
  • High School Diploma/GED and 12 years of Information Systems experience
  • Hands-on experience with Agile / SAFe delivery, DevOps, and CI/CD practices

Nice to have:

  • 1-3 years of Technical Product Manager experience for an AI/Automation product
  • 5–8+ years of experience in Regulatory Information or Document Management process and systems or Clinical/Safety/Labelling Document Management processes and systems
  • 5-8+ years of experience in managing custom software development products
  • Strong experience with computer system validation, GxP, and FDA 21 CFR Part 11
  • Working knowledge of Veeva Vault RIM and regulatory publishing/submission platforms and/or Safety systems (Argus) or Clinical systems (CTMS)
  • Experience in life sciences, healthcare, or similarly regulated industries
  • Hands-on experience with Agile / SAFe delivery, DevOps, and CI/CD practices
  • Familiarity with AWS cloud technologies, data integrations, and analytics
  • Strong ability to influence stakeholders and work effectively with senior leaders
  • Excellent written and verbal communication skills
  • High learning agility and passion for innovation and continuous improvement
  • Strong experience with GenAI development including familiarity with RAG, Prompt Engineering, LLM fine-tuning, and Agentic Architecture
  • Strong experience in developing multi-year product roadmaps and managing a product through every aspect of the software development life cycle
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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