Sr Associate IS Engineer - Clinical Trial Registry System

within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Associate IS Engineer - Clinical Trial Registry System

What you will do

The Sr. Associate IS Engineer - CTRS is responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meets 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 Disclose from Citeline and docuBridge Suite from Lorenz.

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

• Manage software delivery scope, risk, and timeline, ensuring successful project completion.

• Quickly translate concepts into working code, facilitating efficient development cycles.

• Drive efficient and effective software development through a solid understanding of the Software Development Life Cycle.

• Ensure robust and reliable IT service delivery by using ITIL and IT Service Management processes.

• Work closely with business stakeholder to translate business needs into functional and data requirements, providing technical guidance and mentorship to junior developers.

• Contribute to the development and maintenance of ETL pipelines (primarily in Databricks/AWS) that power the disclosure platform by collaborating with vendor partners.

• Ensure the completeness and correctness of disclosure data flows from internal systems to Disclose application from Citeline.

• Conduct UAT and ensure performance and data integrity, developing innovative solutions using generative AI technologies.

• Ensure code quality and alignment to standard processes, creating and maintaining documentation on software architecture, design, deployment, disaster recovery, and operations.

• Include configurations, custom reports, interfaces, and enhancements, analyzing and understanding functional and technical requirements to translate them into software architecture and design specifications.

• Ensure the quality of the software through unit tests, integration tests, and other testing strategies.

• Ensure seamless data flow and functionality, providing ongoing support and maintenance for applications to ensure smooth and efficient operation.

• Design and implement systems and processes, developing and maintaining monitoring tools and dashboards to track system health, performance, and availability.

• Conduct root cause analysis and implement preventive measures, ensuring the implementation and maintenance of 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. The professional we seek is someone with these qualifications.

Basic Qualifications:

• Master's degree / Bachelor's degree and 5 to 9 years of relevant experience

Must-Have Skills

• Demonstrate a deep understanding of pharma industry regulations and compliance requirements, including Clinical Trial Disclosure regulations like FDA and EUCTR.

• Have excellent knowledge of submission publishing systems like Lorenz's docuBridge application, ClinicalTrials.gov, EudraCT, and Regulatory Veeva Vault.

• Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent.

• 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 such as Scaled Agile (SAFe) and ITIL.

• Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.

• Possess 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 stakeholders

• Broad working knowledge of key IS domains and layers

Professional Certifications:

• ITIL (preferred)

• Scaled Agile Framework (SAFe) for Teams (preferred)

• Veeva Vault platform (preferred)

Soft Skills:

• Able to work under minimal supervision

• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work

• 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

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

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.

.