Specialist IS Business Analyst Compliance - Safety DTI

What you will do

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 Amgens 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

What we expect of you

Basic Qualifications:

• Masters degree and 3 to 4 years in regulated industry OR
• Bachelors 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.