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.
Let’s do this. Let’s change the world. In this vital role you will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative demonstrates innovative technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content.
The Technical Product Owner (TPO) for the Structured Content Management/Authoring (SCA) System is responsible for the development, management, and continuous improvement of content authoring tools and platforms operating in a SAFe framework that support the creation, structuring, and delivery of content across multiple channels, primarily responsible for enhancing the value delivered by the team by ensuring that the team backlog is aligned with customer and partner needs. This role involves close collaboration with partners to gather requirements, prioritize features, and guide the development process. The role represents the needs of customers and the business within the Clinical domain and ensures that strategy and implementation remain connected throughout the value stream. The ideal candidate has strong experience in product management, excellent communication skills, and a deep understanding of Agile methodologies.
At Amgen, a Technical Product Owner is responsible for setting, prioritizing, and evaluating the work generated by the product team to ensure outstanding features and functionality of the product. They partner closely with internal and external clients such as content strategists, UX/UI designers, developers, and product managers to facilitate the optimization of processes through the implementation of solutions that enable enterprise-wide capabilities.
Define a vision and long-term strategy for the structured content authoring system, aligning it with business goals and content strategy.
Create, prioritize and maintain the structured content authoring system backlog, balancing immediate user needs with long-term scalability.
Document detailed user stories and acceptance criteria for structured content authoring features, ensuring that content creators, developers, Integration and UX teams clearly understand the requirements.
Work closely with the business teams, Scrum Master and development team to plan and implement sprints, based on business value, technical dependencies, and user feedback, balancing Business objectives with technological feasibility.
Collaborate with data product team to define structured content models that allow for content reuse, modularity, and consistency across multiple filings/documents.
Oversee technical decisions that impact system scalability, performance, and content delivery speed, ensuring a seamless user experience for content authors and end users.
Implement governance mechanisms to ensure that the system aligns with security standards, regulatory requirements, and organizational policies
Act as the point of contact for issues and questions, resolution of service-related incidents and problems, ensuring user satisfaction and minimal impact on business operations
Maintain detailed documentation of service processes, SLAs, and improvement initiatives
Analyze customer feedback and support data to identify difficulties and opportunities for product improvement
Maintain alignment and clear lines of communication with other Technical Product Owners and Program Leadership regarding produce development
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 4 to 6 years of Business Analysis or Product Ownership experience OR
Bachelor’s degree and 6 to 8 years of Business Analysis or Product Ownership experience OR
Diploma and 10 to 12 years of Business Analysis or Product Ownership experience
Preferred Qualifications:
Strong technical background, including understanding software development processes, databases, and cloud-based content systems.
Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements.
Experience with product backlog management (e.g., Jira) and collaboration tools.
Excellent communication skills, with the ability to convey complex technical concepts to non-technical business SMEs and collaborate effectively across technical teams.
Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery.
Experience with structured content management, content models, and modular content creation.
At least 2 – 4 years of domain knowledge in health and/or life sciences combined with Information Technology
Understanding of the Common Technical Document (CTD), Regulatory Affairs and submission filings and related technologies in the areas of Clinical, Safety, Labeling, or Medical writing
Strong understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, M5, M2.7, M2.5 etc.)
Basic understanding of GenAI solutions
SAFe for Teams certification (preferred)
SAFe Product Owner and SAFe Product Manager (preferred)
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.
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.
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.
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.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.