Specialist IS Engineer - System Implementation & Development

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel likeyou’repart of something bigger,it’sbecause 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’llthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let’sdo this.Let’schange the world. In this vitalroleyou willbe responsible fordesigning, developing, andmaintainingsoftware applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions.

Roles & Responsibilities:

• Participate in technical discussions related to theRisk base Quality Management (RBQM)system(s) within Clinical TrialOperationsandSiteEngagement (CTOSE) product team.

• Take ownership of complex software projects from conception to deployment.Build technicalsolutionasper implementation project plan by working with various members of the product team and business partners.

• Possesses strong knowledgeandhands-onexpertiseonapplication/system integrations and backend development

• Possesses strong rapid prototyping skills and can quickly translate concepts into working codealong with managingsoftware delivery scope, risk, and timeline.

• Contribute to both front-end&back-end developmentand Integrationsusing cloud technology& generative AI.

• Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study

• Support requirements gathering and specification creationprocessfor the development work.

• Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements

• Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle.

• Define, author, and present various architecture footprintsi.e.Business, Logical, Integration, Security, Infrastructure, etc.

• Create andmaintaindetaileddocumentation on software architecture, design, deployment, disaster recovery, and operations.

• Conduct code reviews to ensure code quality and adherence to best practices.

• Identifyand resolve technical challenges/bugs/issueseffectivelywithin deadlines.

• Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time.

What we expect of you

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

Basic Qualifications:

• Master's or Bachelor’s degree with8-12years of experience in Computer Science

Preferred Qualifications:

• Solid technical background, including understanding software development processes,application/system integrations,databases, and cloud-based content systems.

• Strong problem solving, analytical skills; Ability to learn quickly; Excellent communication(verbal & written)and interpersonal skills.

• Good knowledgeofscripting language (Java orPython), SQL queries, markup languages (XML, JSON),integration tools (mulesoft,databricks, APIs)andfamiliarity with API-driven content delivery.

• Agile/Scrum experience withdemonstratedsuccess managing product backlogs and delivering iterative product improvements.

• Strong knowledge ofPharma domain& Clinical Trial processes

• Experience with product backlog management (e.g., Jira) and collaboration tools.

Good-to-Have Skills:

• Experience with structured content management, content models, and modular content creation.

• Knowledge of Risk based Quality Management forClinicalTrials

• Understanding ofinternational pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS,USPIetc.).

• Strong understanding of cloud platforms (e.g., AWS, GCP, Azure) and containerization technologies (e.g., Docker, Kubernetes).

• Experience with data processing tools like Hadoop, Spark, or similar.

• Basic und