Job Description

Career Category Information Systems

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, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime.
The ideal candidate will have a solid background in regulatory submissions, along with innovative and ground-breaking experience.
Roles & Responsibilities:

• Collaborate with internal Regulatory Operations collaborators and vendor partner (Lorenz) to ensure accurate interpretation of requirements, delivery of compliant submissions, and successful deployment of the solution.
• Collaborate with multi-functional partners including Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and translate them into scalable, compliant technical solutions.
• Define and manage project plans, timelines, resource allocation, and key achievements to ensure end-to-end project execution - from system assessment, procurement, configuration, validation, release, to post-production support.
• Drive validation and compliance readiness by overseeing the development of validation plans, IQ/OQ/PQ protocols, and related documentation as per GXP, 21 CFR Part 11, and Annex 11 guidelines.
• Ensure regulatory submission readiness by enabling structured document authoring workflows, lifecycle management, and integration with content sources such as Regulatory Veeva Vault.
• Oversee user access controls, role-based privileges, and audit trail configurations to ensure system integrity and security are maintained.
• Own the change control process for the submission system by aligning with ITIL standards and ensuring traceability for all updates, patches, and configuration changes.
• Develop training materials and conduct hands-on user training to onboard regulatory users and business owners, ensuring effective adoption of the system.
• Monitor production performance and work with Lorenz to solve issues, ensuring timely resolution of incidents with minimal impact on business continuity.
• Lead continuous improvement initiatives to enhance system usability, performance, and regulatory compliance alignment.
• Track KPIs and provide regular status updates to leadership and steering committees on system performance, user adoption, and submission throughput.
• Contribute to technology roadmap planning by finding opportunities for tool upgrades, integration with newer modules (e.g., Lorenz eValidator), and regulatory intelligence platforms.
• Act as the SME for structured submissions and represent the function during audits, inspections, and regulatory reviews.
• Possesses strong rapid prototyping skills and can quickly translate concepts into working code.
• Demonstrate adaptability to agile methodology, ensuring flexibility and responsiveness to changing project requirements.
• Manage and lead teams effectively, fostering collaboration and productivity.
• Use Jira and ServiceNow for project tracking, issue resolution, and service management.
• Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations
• Stay updated with the latest trends and advancements
• Analyze and understand the functional and technical requirements of applications, solutions and systems and translate them into software architecture and design specifications.
• Develop and maintain monitoring tools and dashboards to track system health, performance, capacity 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 / Master's degree / Bachelor's degree and 8 to 13 years Computer Science, IT or related field

Preferred Qualifications:
Functional Skills:
Must-Have Skills

• Demonstrate a deep understanding of pharma industry regulations and compliance requirements for, including FDA and EUCTR.
• Have excellent knowledge of submission publishing systems like Lorenz's docuBridge application 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 best practice 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 (please mention if the certification is preferred or mandatory for the role):

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

Soft Skills:

• Excellent analytical and troubleshooting 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 accommodatio
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
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