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:
As a Structured Content Management Business Analyst, you will serve on the structured content management system product team acting as a critical link between Submission Labeling business partners and technical teams, ensuring that structured content management systems are developed and optimized to meet business needs. Your primary responsibility will be to gather, analyze, and document related requirements while ensuring alignment with overall business objectives and content strategy. By translating business goals into detailed technical specifications, you will support the development and enhancement of structured content solutions. This role requires a solid understanding of both business processes and technology in the area of content management, enabling you to collaborate effectively with content strategists, software engineers, and other key partners.
Roles & Responsibilities:
Work closely with business partners and technical teams to understand, elicit, define, and document business requirements related to the structured content management system.
Translate business requirements into clear, detailed technical specifications for structured content systems, including workflows, metadata schemas, content types, and integration requirements.
Document detailed user stories and acceptance criteria for product features, ensuring that business partners, developers, integration and UX teams clearly understand the requirements.
Evaluate current business processes and identify areas where technical solutions can drive improvements, improve efficiency, or reduce costs.
Propose solutions that align with business and technical objectives.
Partner with engineers to assess the feasibility of new features and solutions.
Understand technical constraints and dependencies to ensure that proposed solutions are viable.
Perform data analysis as needed to support decision-making processes.
Maintain alignment and clear lines of communication with Technical Product Owners and developers.
Communicate project progress, timelines, risks, challenges, and provide regular updates and gather feedback to ensure the solution aligns with business needs.
Work closely with the testing team during the testing phase to ensure that all requirements are met.
Assist in the development of test plans and scenarios to validate that solutions meet business requirements
Contribute to change management activities, such as the creation of training materials and user guides to help partners transition to new processes and systems.
Stay up-to-date with the latest technologies, industry trends, and standard methodologies in business analysis and technical project management.
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 1 to 3 years of Computer Science or IT experience OR
Bachelor’s degree and 3 to 5 years of Computer Science or IT experience OR
Diploma and 7 to 9 years of Computer Science or IT experience
Preferred Qualifications:
Must-Have Skills:
Strong problem-solving skills and attention to details in the translation of business needs into detailed technical specifications, user stories, acceptance criteria and process flow diagrams.
Solid technical background, including understanding of 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 tools (e.g. Jira, confluence), and understanding and applied use of SQL queries and Python scripting
Good-to-Have Skills:
Experience with structured content management, content models, and modular content creation.
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
Experience with SaaS solutions, process automation or workflow management tools.
Basic understanding of GenAI solutions
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.
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