Business Systems Analyst - Structured Content Authoring

What you will do

Lets do this. Lets 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.

Basic Qualifications:

• Masters degree and 1 to 3 years of Computer Science or IT experience OR
• Bachelors 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.