Functional Business Analyst

POSITION SUMMARY

DUTIES

• Lead and maintain the centralized DMDQ Knowledge Management Repository in FDA-designated collaboration platforms, organizing SOPs, project and technical documentation, process maps, user guides, business and validation rules, lessons learned, training materials, and knowledge-transfer artifacts.
• Elicit, analyze, document, and validate business and operational requirements with OCS stakeholders, tool teams, service teams, data managers, and technical personnel; translate requirements into clear process, workflow, reporting, and modernization needs.
• Document and continuously improve business processes supporting study data acquisition, validation, loading, curation, data quality, governance, reporting, workflow automation, system integration, incident/change management, and operational support.
• Develop, review, and maintain SOPs and operating guides; ensure documentation is technically accurate, logically organized, version controlled, and updated as procedures, policies, business rules, or systems change.
• Plan and facilitate knowledge-transfer, cross-training, system walkthroughs, process demonstrations, lessons-learned sessions, and Government training to reduce key-person dependency and preserve continuity of operations.
• Support Task 3.2 data-quality reporting and Task 3.4 modernization through requirements analysis, user stories/use cases, acceptance criteria, UAT coordination, process impact analysis, and traceability between business needs and implemented capabilities.
• Track documentation status, knowledge gaps, training needs, and process-improvement opportunities; provide metrics and recommendations to the Project Manager and FDA stakeholders.

EDUCATION

REQUIRED QUALIFICATIONS

• Demonstrated experience leading business analysis, requirements elicitation, process mapping, SOP/document development, knowledge management, and stakeholder facilitation in complex technical or regulated environments.
• Ability to translate operational and technical information into clear, actionable documentation for business, scientific, and technical audiences.
• Experience with document repositories, version control, workflow/process documentation, requirements traceability, and quality review of deliverables.
• Strong written communication, facilitation, organization, and cross-functional coordination skills.
• Must be able to obtain and maintain a High-Risk Public Trust or equivalent federal client access. This role supports sensitive federal programs and involves elevated access to systems and data.
• Position requires the current ability to obtain and maintain required access without interruption in alignment with long-term program needs.
• Must be authorized to work in the United States without employer sponsorship now or in the future.

PREFERRED QUALIFICATIONS

• Prior FDA/CDER, pharmaceutical, biotechnology, clinical-data, or Federal health experience; familiarity with study-data workflows, data quality/governance, CDISC concepts, SharePoint, Jira or similar work-management tools, Agile delivery, EPLC documentation, and modernization or transition activities.

ABOUT APV