Business Analyst

AARK Tech Solutions GmbH is seeking a Business Analyst to manage and document business requirements within the healthcare and life sciences domain. The role includes collaborating with various stakeholders and ensuring solutions align with healthcare regulations while supporting project methodologies.

Responsibilities:

• Manage, analyze, validate, and document business, functional, and non-functional requirements using interviews, workshops, and document analysis
• Create clear and detailed artifacts such as BRDs, FRDs, user stories, use cases, process flows, and data models
• Act as a liaison between business stakeholders, product owners, and technical teams to ensure shared understanding of requirements
• Support Agile/Scrum or Waterfall project delivery methodologies as applicable
• Work with stakeholders across payer, provider, pharma, biotech, medical devices, or CRO environments
• Understand and document workflows related to any of these: Clinical trials and clinical data management, Drug development lifecycle and pharmacovigilance, Healthcare claims, enrollment, billing, and reimbursement, EHR/EMR systems and interoperability
• Ensure solutions align with healthcare regulations and standards such as HIPAA, FDA 21 CFR Part 11, GxP, HL7, FHIR, ICD-10, CPT
• Collaborate with data teams to define reporting and analytics requirements
• Support data validation, UAT, and reconciliation activities
• Analyze healthcare datasets to identify trends, gaps, and improvement opportunities
• Facilitate requirement walkthroughs, sprint reviews, and UAT sessions
• Support change management by assessing impact and updating documentation
• Assist project managers with scope control, risk identification, and dependency tracking

Requirements:

• Manage, analyze, validate, and document business, functional, and non-functional requirements using interviews, workshops, and document analysis
• Create clear and detailed artifacts such as BRDs, FRDs, user stories, use cases, process flows, and data models
• Act as a liaison between business stakeholders, product owners, and technical teams to ensure shared understanding of requirements
• Support Agile/Scrum or Waterfall project delivery methodologies as applicable
• Work with stakeholders across payer, provider, pharma, biotech, medical devices, or CRO environments
• Understand and document workflows related to clinical trials and clinical data management
• Understand and document workflows related to drug development lifecycle and pharmacovigilance
• Understand and document workflows related to healthcare claims, enrollment, billing, and reimbursement
• Understand and document workflows related to EHR/EMR systems and interoperability
• Ensure solutions align with healthcare regulations and standards such as HIPAA, FDA 21 CFR Part 11, GxP, HL7, FHIR, ICD-10, CPT
• Collaborate with data teams to define reporting and analytics requirements
• Support data validation, UAT, and reconciliation activities
• Analyze healthcare datasets to identify trends, gaps, and improvement opportunities
• Facilitate requirement walkthroughs, sprint reviews, and UAT sessions
• Support change management by assessing impact and updating documentation
• Assist project managers with scope control, risk identification, and dependency tracking
• Strong experience as a Business Analyst in Healthcare and/or Life Sciences
• Solid understanding of healthcare business processes and regulatory environments
• Experience with Agile (Scrum/Kanban) and/or Waterfall methodologies
• Proficiency in requirement management tools (e.g., JIRA, Confluence, Azure DevOps)
• Ability to create process flows, wireframes, and data mappings
• Strong analytical, problem-solving, and documentation skills
• Excellent communication and stakeholder management skills
• Ability to work effectively with cross-functional and global teams
• High attention to detail with a proactive and collaborative mindset
• Experience working with APIs, healthcare integrations, or data platforms is a plus