Specialist IS Business Systems Analyst - Regulatory Information Management (RIM)

Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the struggle 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 in Thousand Oaks, CA as a Specialist IS Business Systems Analyst specializing in data modeling and integration support (also known as "data architect") on a large-scale Regulatory Information Management (RIM) transformation program. The successful person will play a key role in Amgen's RIM product team.

Job Summary

The core duties of this position are to partner with all internal and external program stakeholders. You will contribute to the success of the program by designing and making fundamental improvements to the RIM data architecture including how information is managed, cross-functional business processes are operated, and work flow is directed to efficiently achieve the integration and orchestration of all activities required for RIM. You will also attend strategic multi-functional meetings to facilitate the optimization of processes through implementation of solutions that enable enterprise-wide RIM data integrations. You also will work and collaborate with the IS Technical Architects to determine the best technical solutions for the program.

You will be a participant in all phases of the RIM Product Development Life Cycle (PDLC) including: business client expectation and requirement documentation, process and systems analysis, and articulating system solutions and approaches for addressing business needs pertaining to cross-systems integration requirements and design.

This role entails the integration of commercial off the shelf (COTS) application platforms focused on RIM for Life Sciences and systems across R&D and Operations. A deep understanding of RIM processes, incl. authoring is helpful, but not required. You will also be required to gain in-depth business domain knowledge, perform data modeling, facilitate and document business requirements via client sessions and workshops for complex and multi-segment business processes, and help translate and communicate the requirements to the technical design and development team.

Basic Qualifications

Doctorate degree

OR

Master's degree and 2 years of directly related experience

OR

Bachelor's degree and 4 years of directly related experience

OR

Associate degree and 10 years of directly related experience

OR

High School / GED and 12 years of directly related experience

Preferred Qualifications

• Experience engaging with business users to analyze business needs, capture and document business and solution requirements around systems integrations
• Demonstrated knowledge and proficiency in intermediate SQL and data modeling
• Experience in designing and implementing reporting and analytics solutions in Spotfire, Tableau, Cognos, etc.
• Experience in working with technical teams in the implementation of systems integrations preferably using ESD technologies including Mulesoft and ETL technologies like Informatica
• Knowledge of industry data standards such as eCTD, SPL, IDMP, CDISC, etc.
• 5+ 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, handle 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
• Knowledge of and experience with Agile project methodologies and working in Product teams
• 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

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we ensure a diverse and inclusive work environment.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.