ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
ABOUT THE 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 leveragesstate-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content.
Role Description:
This role is a key contributor to bridging the gap between business processes and technical development, supporting data sourcing and integration for regulatory filings. This role combines domain expertise and analytical skills to gather, refine, and document product requirements, including epics, user stories, business process maps, and test plans. Collaborating closely with developers, Product Managers, and business stakeholders, the analyst ensures technical requirements are well-defined, enabling accurate planning, estimation, and delivery of high-quality software solutions. Responsibilities also include sourcing and integrating data, ensuring its accuracy and alignment with regulatory needs, and developing test cases to validate system performance and compliance.
In addition to requirements analysis, this role emphasizes understanding how businesses create, consume, and make decisions using data in the context of their processes. The analyst analyzes how and where data is created, managed, and moved through business processes, software systems, and technologies. With strong SQL skills, they extract, manipulate, and analyze data from source systems and databases, ensuring clean, organized, and usable information for decision-making. They also bring a solid understanding of CDL and semantic layers, enabling efficient data organization and accessibility. Acting as a liaison, the analyst provides insights to stakeholders, optimizes processes, ensures consistent practices across teams, and contributes to regulatory compliance and reporting. With a proactive approach to problem-solving and collaboration, this role drives continuous improvement and ensures the success of program objectives.
Roles & Responsibilities:
Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals
Capture the voice of the customer to define business processes and product needs
Work with Product Managers and customers to define scope and value for new developments
Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog
Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs
Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team
Clearly express features in User Stories/requirements so all team members and stakeholders understand how they fit into the product backlog
Ensure Acceptance Criteria and Definition of Done are well-defined
Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs
Stay focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders
Develop and execute effective product demonstrations for internal and external stakeholders
Maintain accurate documentation of configurations, processes, and changes
Basic Qualifications and Experience:
Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Functional Skills:
Must-Have Skills:
Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
Experience with SAFe Framework and Agile software development methodologies (Scrum)
Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
Experience in writing requirements for development of modern web application
Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA
Good-to-Have Skills:
Demonstrated expertise in a scientific domain area and related technology needs
Understanding of scientific software systems strategy, governance, and infrastructure
Experience in managing product features for PI planning and developing product roadmaps and user journeys
Familiarity with low-code, no-code test automation software
Technical thought leadership
Able to communicate technical or complex subject matters in business terms
Jira Align experience
Experience of DevOps, Continuous Integration, and Continuous Delivery methodology
Professional Certifications
SAFe for Teams certification (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
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.