Specialist IS Engineer

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.

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime.

The ideal candidate will have a strong background in regulatory submissions and clinical trials, along with innovative and transformational experience.

Roles & Responsibilities:

• Take ownership of complex software projects from conception to deployment
• Manage software delivery scope, risk, and timeline
• Possesses strong rapid prototyping skills and can quickly translate concepts into working code
• Provide technical guidance and mentorship to junior developers
• Contribute to both front-end and back-end development using cloud technology
• Develop an innovative solution using generative AI technologies
• Conduct code reviews to ensure code quality and alignment to standard methodologies
• Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations
• Stay updated with the latest trends and advancements
• Work closely with the product team, business team, and other partners
• Design, develop, implement, and maintain applications, including configurations, custom reports, interfaces, and enhancements
• Analyze and understand the functional and technical requirements of applications, solutions and systems, and translate them into software architecture and design specifications
• Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software
• Work on integrating applications with other systems and platforms to ensure seamless data flow and functionality
• Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently
• Design and implement systems and processes to improve the reliability, scalability, and performance of applications
• Develop and maintain monitoring tools and dashboards to track system health, performance, and availability
• Respond to and resolve incidents promptly, conducting root cause analysis and implementing preventive measures
• Implement and maintain security measures to protect systems from unauthorized access and other threats

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR
• Master’s degree and 4 to 6 years of Computer Science, IT or related field experience OR
• Bachelor’s degree and 6 to 8 years of Computer Science, IT or related field experience OR
• Diploma and 10 to 12 years of Computer Science, IT or related field experience

Preferred Qualifications:

Functional Skills:

Must-Have Skills

• Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements
• Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline
• Have knowledge of ClinicalTrials.gov and EudraCT
• Have good knowledge of Regulatory Veeva Vault
• Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent.
• Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc.
• Strong knowledge of information systems and network technologies

Good-to-Have Skills:

• Strong knowledge of eCTD specification and highly regulated (GxP) systems
• Experience in a leadership role within a pharmaceutical or technology organization
• Extensive experience in the software development lifecycle of GxP Systems.
• Experience using and adoption of Scaled Agile Framework (SAFe)
• Strong analytical/critical-thinking and decision-making abilities.
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business partners
• Broad working knowledge of key IS domains and layers

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

• ITIL (preferred)
• Scaled Agile Framework (SAFe) for Teams (preferred)
• Veeva Vault platform Certified (preferred)

Soft Skills:

• Excellent analytical and solving 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 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.

Equal opportunity statement

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.

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com