25 days old

Sr. Associate IS Business Systems Analyst - Regulatory Information Systems

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115601230
Amgen

Job ID: R-87181
Location: Thousand Oaks, CA, US 91360

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.

This role within the Development Information Systems group will support clinical development at Thousand Oaks with a focus on Regulatory Affairs. As a business analyst, you will define requirements, facilitate design, configure applications, and support solution deployment working with partners in the Regulatory Affairs organization including Promotional Materials Management, Regulatory Operations, and other groups while adhering to Amgen standards, policies and procedures.

Responsibilities:
  • Work with multi-functional representatives across all Regulatory Affairs functions to align Product Development processes with core platform technologies like Veeva Vault and others
  • Actively engage with business users to analyze business needs, capture and detail business and solution requirements guided by standard methodologies in core application platforms and Agile
  • Coordinate workshops and proof-of-concepts to illustrate business capabilities and facilitate adoption by business
  • Provide technical leadership and improve solutions approach via hands-on configuration of solutions
  • Support selection of new technologies as needed, and development of Technology Roadmap for the domain architecture


Required Qualifications

Master's degree

Or

Bachelor's degree and 2 years of Information Systems and/or Business Analysis experience

Or

Associate's degree and 6 years of Information Systems and Business Analysis experience

Or

High school diploma / GED and 8 years of Information Systems and Business Analysis experience

Preferred Qualifications
  • You have a Bachelor Degree in Information Systems, Computer Science, Business, Engineering or Life Sciences and 2+years related experience in Information Systems/Technology or Engineering
  • You are able to navigate, facilitate and work within a complex matrix organization
  • You are used to working with internal business clients in a business analyst capacity to understand their business processes, handle scope of work/expectations and suggest/recommend IS solutions
  • You have knowledge of, and experience with, implementing and supporting COTS (configurable off the shelf) applications in the life sciences industry
  • You are passionate about hands-on work and bring expertise in configuration with Veeva Vault or other COTS.
  • You have working knowledge of Agile project methodologies and working in Product teams
  • You have shown excellent written, presentation, and verbal interpersonal skills, including demonstrable experience presenting technology recommendations from a business perspective
  • You have experience with working in the biotech/pharmaceutical industry and current approaches to GxP computer related systems


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 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.

The invaluable contributions of our talented Tampa team will help us develop the vital and innovative medicines that treat serious illness and unmet medical needs around the globe.

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.

PI115601230

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87181<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>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.<br><br>This role within the Development Information Systems group will support clinical development at Thousand Oaks with a focus on Regulatory Affairs. As a business analyst, you will define requirements, facilitate design, configure applications, and support solution deployment working with partners in the Regulatory Affairs organization including Promotional Materials Management, Regulatory Operations, and other groups while adhering to Amgen standards, policies and procedures.<br><br><b>Responsibilities:</b><br><ul><li>Work with multi-functional representatives across all Regulatory Affairs functions to align Product Development processes with core platform technologies like Veeva Vault and others</li><li>Actively engage with business users to analyze business needs, capture and detail business and solution requirements guided by standard methodologies in core application platforms and Agile</li><li>Coordinate workshops and proof-of-concepts to illustrate business capabilities and facilitate adoption by business</li><li>Provide technical leadership and improve solutions approach via hands-on configuration of solutions</li><li>Support selection of new technologies as needed, and development of Technology Roadmap for the domain architecture</li></ul><br><br><b> Required Qualifications </b><br><br>Master's degree<br><br>Or<br><br>Bachelor's degree and 2 years of Information Systems and/or Business Analysis experience<br><br>Or<br><br>Associate's degree and 6 years of Information Systems and Business Analysis experience<br><br>Or<br><br>High school diploma / GED and 8 years of Information Systems and Business Analysis experience<br><br><b> Preferred Qualifications </b><br><ul><li>You have a Bachelor Degree in Information Systems, Computer Science, Business, Engineering or Life Sciences and 2+years related experience in Information Systems/Technology or Engineering</li><li>You are able to navigate, facilitate and work within a complex matrix organization</li><li>You are used to working with internal business clients in a business analyst capacity to understand their business processes, handle scope of work/expectations and suggest/recommend IS solutions</li><li>You have knowledge of, and experience with, implementing and supporting COTS (configurable off the shelf) applications in the life sciences industry</li><li>You are passionate about hands-on work and bring expertise in configuration with Veeva Vault or other COTS.</li><li>You have working knowledge of Agile project methodologies and working in Product teams</li><li>You have shown excellent written, presentation, and verbal interpersonal skills, including demonstrable experience presenting technology recommendations from a business perspective</li><li>You have experience with working in the biotech/pharmaceutical industry and current approaches to GxP computer related systems</li></ul><br><br>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.<br><br>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.<br><br>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.<br><br>The invaluable contributions of our talented Tampa team will help us develop the vital and innovative medicines that treat serious illness and unmet medical needs around the globe.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/Z4nAwlfyW2OyuxqmIbXn4"> <p>PI115601230</p>

Categories

Posted: 2019-11-19 Expires: 2019-12-20

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Sr. Associate IS Business Systems Analyst - Regulatory Information Systems

Amgen
Thousand Oaks, CA 91360

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