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

Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers creative 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.

Are you passionate about defining and implementing innovative systems solutions for your customers? Then this role is for you! Amgen is seeking an experienced professional to work in Thousand Oaks, CA as a Principal IS Business Systems Analyst. The individual will play an important role in transforming and innovation in advancing the high-impact space of Regulatory Information Management (RIM) with our next generation platforms and technologies. The responsibilities will include leading product teams to deliver various new RIM solutions.

Responsibilities:

• Fulfills a project leadership role of educating, motivating and advising in execution and maintenance of new and existing service offerings to enrich business area strategy as a whole

• Applies expert-level knowledge of RIM in driving the development of business and technical requirements, exploration of solution options, vendor management, and run/build operations

• Works with business, product team, data and insights & enterprise reporting/architecture teams to architect, design, prototype, and develop solutions that enable quality RIM solutions

• Applies and re-use global technology capabilities and standards and deliver business differentiated platforms and solutions

• Uses cross-functional governance for prioritization of business demand captured in product backlogs

• Encourages and leads a team of business analysts, software analysts and developers

• Keeps up to date on new industry and emerging technology to drive competitive advantage and groundbreaking innovation

• Supports business and system capability planning and roadmap for RIM solutions

Basic Qualifications:

• Doctorate degree and 2 years of Information Systems experience

• OR Masters degree and 4 years of Information Systems experience

• OR Bachelors degree and 6 years of Information Systems experience

• OR Associates degree and 10 years of Information Systems experience

• OR High School Diploma /GED and 12 years of Information Systems experience

Preferred Qualifications:

• At least 5 8 years of domain knowledge in RIM process and systems, computer systems validation, GCP, and FDA 21 CFR Part 11

• Working knowledge of Veeva Vault RIM preferred but not required

• Background in health and/or life sciences and Information Technology

• Ability to set expectations with business partners and optimally use governance for a positive business partner experience

• Strong communications skills in writing, speaking, presenting and time management skills

• 3+ years experience in managing and building product teams in RIM while keeping focus on clients

• 5 + years business systems analysis/business process improvements and support experience with various types of Software Development Life Cycles methodologies

• Demonstrable ability to influence and work well with senior level executives to drive business value

• Experience with AWS cloud and/or a AWS Certified Cloud Practitioner

• Knowledge of Architecting Data and Analytics and visualization solutions on cloud (AWS or Other)

• Knowledge of DevOps, Continuous Delivery, and Agile product development

• Ability to motivate people and instill ownership, reliability, teamwork, and dedication in the team

• Must be creative to deliver innovative solutions to address critical business problems

• Has high learning agility

We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, 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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.