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Sr Associate IS Business Systems Analyst

Job Profile

Sr Associate IS Bus Sys Analyst

Job Description

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you are part of something bigger, it’s because you are. Our shared

mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our

fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare

Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients

as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is

collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as

part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let’s do this. Let’s change the world. In this vital role, you will work with cross-functional teams to support GRC processes for IS and GxP.

You will monitor GxP records, support IS CDOCs document management, assess potential compliance risks, track remediation actions, and

contribute to regulatory compliance through evidence collection and reporting. You will also troubleshoot issues, support end users, and contribute to IT projects and process improvements.

Roles & Responsibilities:

GRC Monitoring and Risk Support

Identify and assess potential compliance risks through GxP and IS CDOCs monitoring, and escalate concerns to the process owner.

GxP Compliance Support

• Monitor GxP deviation, CAPA, and CAPA-EV records for status, due dates, completeness, and required follow-up.
• Follow up with record owners on routine actions and escalate overdue items, gaps, or potential compliance concerns to the process owner.
• Respond to routine GxP process questions and guide users on record requirements and established procedures.
• Support GxP office hours, process guidance sessions, and stakeholder meetings; help identify recurring questions or process issues.

IS Document Management (CDOCs)

• Review IS CDOCs reports and workflows to track open actions, aging documents, upcoming periodic reviews, and approval or routing issues.
• Follow up with document owners and stakeholders to support timely reviews, revisions, and approvals.
• Provide routine process guidance to document owners, authors, reviewers, and approvers on established CDOCs requirements.
• Support document traceability, version control, office hours, and stakeholder meetings; escalate workflow or compliance issues as needed.

Stakeholder Communication

• Collaborate with IS, cybersecurity, quality, and business stakeholders to resolve issues and support process needs.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications & Experience:

Bachelor’s degree and 5–9 years of relevant experience in computer science, information technology, cybersecurity, risk management, or a related field;

Functional Skills:

Must-Have Skills:

• Solid understanding of IT infrastructure, systems, and standard processes.
• Excellent problem-solving, analytical, and communication skills.
• Hands-on experience with electronic document management systems (e.g., Veeva/CDOCs) and quality management systems (e.g., TrackWise) in regulated environments.

Good-to-Have Skills:

• Ability to understand and interpret policies, standards, and regulatory requirements (e.g., CDOCs, GxP, FDA 21 CFR Part 11) with guidance.
• Knowledge of Computer System Validation (CSV)
• Awareness of reporting, automation, or AI-enabled approaches to improve IS process efficiency and documentation quality.
• Experience with ChatGPT or Copilot.
• Experience with SharePoint.

Soft Skills:

• Strong verbal and written communication skills

• Ability to work effectively with global, virtual teams

• Ability to manage multiple priorities successfully

• Team-oriented, with a focus on achieving team goals

• Strong presentation and public speaking skills

Type-Full time

Scheduled Weekly Hours-40

Work Shift-Flexi Shift (India)