Join Amgen's Mission to Serve Patients
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Specialist IS Business Analyst Compliance - Safety DTI
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will lead and support Compliance activities supporting patient safety and adhering to regulatory requirements from around the world for adverse events. This involves compliance related activities to support the Global Patient Safety organization by analyzing data, identifying areas of improvement, and facilitating the implementation of compliance strategies. You will be an active participant in the team directly working towards creating a robust framework that supports regulatory compliance, minimizes risks, and enhances our processes' overall integrity and quality.
Partner with IS and Business stakeholders to analyze and understand business needs by improving and addressing process gaps and enabling automation
Responsible for developing compliance-related documentation
Measure the effectiveness of compliance through targeted metrics and feedback mechanisms, adjusting strategies as needed.
Analyze and explore industry trends and standard methodologies for innovative solutions for Global Patient Safety (GPS)
Improve Amgen’s maturity posture related to Compliance. Support the ongoing assessment activities.
Assist and inform team members with Record Retention requirements
Address records and information management capabilities and practices in support of existing and evolving information and compliance risks
Responsible for supporting and leading technical root cause analysis
Supports PV audits/inspections
Support the Senior Manager in training initiatives and regulatory adherence
Responsible for mentoring the product teams
Win
What we expect of you
Basic Qualifications:
Master’s degree and 3 to 4 years in regulated industry OR
Bachelor’s degree and 5 to 6 years in regulated industry OR
Diploma and 9 to 10 years in regulated industry experience
5+ years of experience within a regulated industry
Strong written and oral communication skills to efficiently communicate within the organization.
Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11, GxP Compliance, and change control
Problem-solving skills, with experience in Root Cause Analysis, Non-Conformance, and Deviation investigations.
Strong communications skills in writing, speaking, communicating and time management skills
SAFe Agile SCM certification is a plus.
Ability to effectively facilitate and drive organizational change.
Has high learning agility, problem solving and analytical thinking
Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with data
Collaborative spirit and effective communication skills to work seamlessly in a cross-functional team
An ongoing commitment to learning and staying at the forefront of AI/ML advancements.
Preferred Qualifications:
Demonstrated expertise in a scientific domain area and related technology needs
Understanding of scientific data strategy, data governance, data infrastructure
Experience with cloud (e.g. AWS) and on-premise compute infrastructure
Experience with stakeholder management, leading a team of 20, ensuring seamless coordination across teams and driving the successful delivery of technical projects
Familiarity with data analytics and scientific computing platforms such as Databricks, Dash, Plotly, Spotfire and related programming languages like SQL, python
Experience creating impactful slide decks and communicating data
Ability to drive projects/company initiatives using Agile methodology
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.
Professional Certifications:
SAFe for Teams certification (preferred)
SAFe Product Owner and SAFe Product Manager (preferred)
Soft Skills:
Excellent leadership, coaching and team management skills.
Strong transformation and change management experience.
Exceptional collaboration and communication skills.
High degree of initiative and self-motivation.
Ability to handle multiple priorities successfully.
Team-oriented with a focus on achieving team goals.
Strong presentation and public speaking skills.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 with 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 an accommodation.