Specialist IS Business Systems Analyst
Amgen is seeking an experienced Business Systems Analyst to join the multi-site Research & Development Informatics organization at its main headquarters in Thousand Oaks, CA. The Business Systems Analyst will join the Global Development Operations - Information Systems team (GDO-IS). The GDO-IS team manages applications and systems used by Global Development Operations from Clinical Trial Design through Study Start Up and Study Conduct and Close Out. Because Clinical Development is flexible and adaptive, this team succeeds by embracing a high-degree of collaboration, open communication, comprehensive analysis, and agile decision-making.
The Analyst will work closely with business partners within Global Development Operations and IS colleagues to develop, implement and advance technical solutions to enable the Clinical Study Conduct and Close Out function and processes. With Business and Information Systems strategy in mind, the analyst will lead, maintain, and drive digital innovation for Amgens electronic Trial Master File (Amgen eTMF) and other key systems in support of this critical function. The Amgen eTMF is built within the Veeva Vault platform and supported by data processing and management capabilities of an Enterprise Data Lake.
Primary activities of the Business Systems Analyst include:
- Partnering with business counterparts to identify strategic and critical business needs and apply a thorough technical understanding of Veeva solutions and Enterprise Data Lake technology to inform system roadmaps to enable these outcomes
- Working as a technology platform specialist within a product team responsible for the continuous digital innovation of the Trial Master File capability and related Enterprise Data Lake components, providing Veeva solutions subject matter expertise while liaising with business stakeholders
- Continuously advancing technical knowledge and depth of understanding of Veeva solutions in order to provide up-to-date technology solutions to meet business needs
- Developing business cases to communicate and request funds for digital innovation opportunities, including the scope, timeline, and resources vital to achieving successful outcomes
- Leading multi-functional teams comprising of business process owners, IS staff, and external partners to evaluate, identify and develop solutions using the newest technologies to advance clinical development operations
- Handling the successful delivery of projects and programs with appropriate planning, financial, resource, vendor and risk management, using agile approaches to maintain a healthy balance of scope, resources, quality, and timelines
- Working with IS leads and Project Managers to align delivery timelines across multiple systems in the technology ecosystem
- Providing subject matter expertise and rapid response to requests for information during health authority inspections
- Leading all aspects of project delivery and ensuring alignment to Information Systems Standard Operating Procedures and Amgen policies
Domestic travel up to 15% may be necessary
This position is open to remote workers within United States, and remote workers may expect travel requirements up to 25%
Masters degree and 3 years of Information Systems and/or Business Analysis and/or Project Management experience
Bachelors degree and 5 years of Information Systems and/or Business Analysis and/or Project Management experience
Associate degree and 10 years of Information Systems and/or Business Analysis and/or Project Management experience
High school diploma/GED degree and 12 years of Information Systems and/or Business Analysis and/or Project Management experience
- Degree in Life Sciences, Computer Science or Engineering
- 4+ years of Business Analysis experience in the pharmaceutical or biotech industry
- Expertise in translating business requirements to technical requirements and recommend solutions
- Demonstrated ability to coordinate/lead multiple projects/activities running simultaneously
- Good communication, teamwork, and collaboration skills
- Working experience with agile SDLC delivery methodology
- Experience with cloud and data lake technologies
- Experience working in a regulated environment
- Experience in analyzing business processes and identifying appropriate technology enablers
- Experience managing applications enabled by Veevas Vault platform
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Join UsIf 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.