Regulated Information Management (RIM) Engineer

Thousand Oaks, CA, US
Mar 22, 2019
Required Education
Position Type
Full time
Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.

Amgen is seeking an experienced professional to work as a Specialist IS Regulated Document Management on a large-scale transformation program. The successful individual will play a key role in Amgen's RIM product team. The incumbent will be responsible for consulting Business Partners on and technically configuring capabilities related to RIM. The incumbent will support deployment of RIM capabilities during program roll-out and will provide continued thought leadership and technical hands-on expertise to Amgen business stakeholders post-deployment. The incumbent will help shape the multi-year RIM product roadmap in alignment with the platform vendor and the business stakeholders.

The core duties of this position are to partner with all internal and external Program stakeholders.

Job Summary

The incumbent will be an active participant in all phases of the RIM Product Development Life Cycle (PDLC) including: business client expectation and requirement scope management, process and systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, and supporting the development of business cases for proposed solutions. Big focus of this role will be on technically configuring solutions during steady state.

This role entails the implementation, integration, and support of commercial off the shelf (COTS) application platforms focused on RIM for Life Sciences. A solid understanding of RIM processes, incl. Authoring is required. This role involves vendor management activities ensuring that project delivery is on time, on budget, and of a quality that meets business expectations. This position requires extensive hands-on experience with and understanding of PDLC concepts and approaches, ability to manage ongoing system enhancements releases, and change control process. This individual is required to gain in-depth business domain knowledge, perform business modeling, facilitate process mapping and business requirements gathering sessions for medium complex and multi-segment business processes, manage client expectations and configure system settings.

Basic Qualifications

Doctorate degree
Master's degree and 2 years of Information Systems and/or Computer Science experience
Bachelor's degree and 4 years of Information Systems and/or Computer Science experience
Associate's degree and 10 years of Information Systems and/or Computer Science experience
High school diploma / GED and 12 years of Information Systems and/or Computer Science experience

Preferred Qualifications
  • 5 or more years related experience in Information Systems/Technology or Engineering
  • Ability to navigate, facilitate and work within a complex matrix organization
  • Ability to work with internal business clients to understand their business processes, manage scope of work/expectations and suggest/recommend IS solutions
  • Knowledge of, and experience with, implementing and supporting COTS Regulated Document Management applications in the life sciences industry
  • Hands-on configuration experience with Veeva Vault RIM strongly preferred. Alternatively, a strong desire to grow into a hands-on configurator role is required
  • Knowledge of and experience with Agile project methodologies and working in Product teams
  • Extensive experience in leading the IS change control process and managing business client expectations
  • Experience and/or understanding of private and multi-tenant cloud deployments and enterprise integrations
  • Excellent written, presentation, and verbal communication skills, including demonstrated experience presenting technology recommendations from a business perspective
  • Knowledge of the biotech/pharmaceutical industry and current approaches to GxP computer related systems
  • Master's Degree in Information Systems, Computer Science, Business, Engineering or the Life Sciences

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.