Career Category

Job Description

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 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.

Role Description:

The Technical Product Owner is responsible for defining the vision & strategy for a CMC Regulatory Submission GenAI product operating in a SAFe framework, 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 Chemistry, Manufacturing and Controls (CMC) 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 to facilitate the optimization of processes through the implementation of solutions that enable enterprise-wide capabilities.

Roles & Responsibilities:

• Define and communicate the product vision, ensuring alignment with business goals

• Create, prioritize, and maintain the product backlog, ensuring that it reflects the needs of the business and partners

• Collaborate with partners to gather and document product requirements, user stories, and acceptance criteria

• Work closely with the business teams, Scrum Master and development team to plan and implement sprints, ensuring that the highest priority features are delivered

• Find opportunities to improve the product and development process, and make data-driven decisions to enhance the product

• Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements

• Manage relationships with vendors, ensuring that service levels are met and that the organization derives the best value from its investments

• Ensure that products align with security standards, regulatory requirements, and organizational policies

• Oversee the resolution of service-related incidents and problems, ensuring 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

• Support, develop, and guide business analysts in performing requirement gathering, documentation, and partner engagement

• Maintain alignment and clear lines of communication with other GenAI Product Owners and Program Leadership regarding produce development

What we expect of you

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

Basic Qualifications:

• 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:

Must-Have Skills:

• Strong knowledge of Agile methodologies and product management principles

• Experience eliciting, documenting, and communicating business requirements in a manner aligned with business expectations and clear to technical developers.

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

• Strong understanding of custom developed technologies and GenAI capabilities

Good-to-Have Skills:

• Experience with custom GenAI solutions

• Solid understanding of the Clinical domain in a regulatory submission context

• Solid understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, M3, M2.3 etc.)

• 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

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.

Professional Certifications:

• SAFe for Teams certification (preferred)

• SAFe Product Owner and SAFe Product Manager (preferred)

Work Hours:

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com