Sr Associate Business Analyst

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 leverages state-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:

Th is role plays a pivotal role in bridging the gap between business processes and technical development to support data sourcing for regulatory filings. Leveraging domain expertise and analytical skills, this role involves gathering, refining, and documenting product requirements as epics, user stories, business process maps, and test plans. By collaborating with developers, Product Managers, and business stakeholders, the analyst ensures that technical requirements are clearly defined, enabling accurate planning, estimation, and delivery of high-quality software solutions. This includes 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 requirement analysis, the analyst is responsible for optimizing processes, maintaining consistency across teams, and ensuring the quality of deliverables. Acting as a liaison between stakeholders, they provide insights and communicate technical concepts in an accessible way to support informed decision-making. The role demands a focus on regulatory compliance, ensuring all data and processes meet applicable standards while enabling efficient and accurate reporting. With a proactive approach to problem-solving and collaboration, this role contributes significantly to achieving program objectives and continuous improvement initiatives.



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:

Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR

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 delegat ing 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