Associate IS - ICSR Intake

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re 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.

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

What you will do

As a Associate IS Analyst, you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting existing & future technologies. In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions. You'll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently.

Roles & Responsibilities:

• Monitor daily Intake processes to identify and resolve issues where files are delayed or stuck.
• Handle system and file reconciliation issues, collaborating with teams to resolve root causes and implement solutions.
• Work with various internal and external teams to address system dependencies and mitigate bottlenecks.
• Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability.
• Collaborate with stakeholders to provide updates and ensure visibility in issue resolution.
• Develop and refine dashboards or reports to track system performance and file flow metrics.
• Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement.
• Responsible for ensuring that intake compliance is adhering to the KCI metrics on a regular basis
• Develop and implement test plans, scripts to validate system updates, patches and new deployments
• Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them.
• Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities.
• Automate repetitive testing processes and improve testing efficiency.

What we expect of you

Basic Qualifications and Experience:

• Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
• Diploma and 4 to 7 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

Functional Skills:

Must-Have Skills

• Strong analytical and problem-solving skills to diagnose and resolve system-related issues.
• Experience with File transfer processes and tackle stuck or delayed files.
• Knowledge of testing methodologies and quality assurance standard processes.
• Proficiency in working with data analysis and QA tools.
• Knowledge of writing SQL will be helpful
• Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP
• Familiarity with ITIL process

Good-to-Have Skills:

• Knowledge or some experience in database programming using SQL
• Some understanding of API integrations such as MuleSoft
• Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients
• Sharp learning agility, problem solving and analytical thinking
• Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control
• Knowledgeable in reporting tools (e.g. Tableau)

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• SAFe for Teams certification (preferred)

Soft Skills:

• Able to work under minimal supervision
• Skilled in providing oversight and mentoring team members.
• Demonstrated ability in effectively collaborating with cross functional teams
• Excellent analytical and gap/fit assessment skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills

Shift Information:

This Individual Contributor position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

For a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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.