Senior Business Analyst - Pharma R&D & Compliance

Ipsen Biopharmaceuticals Inc.; Paris; On-site; EUR 85,000 - 120,000; Full time

Job summary

Ipsen Pharma (SAS) seeks a Senior Business Analyst to partner with R&D, Medical, and IT to deliver compliant, scalable digital solutions. You will define and manage business requirements, analyze processes, and ensure alignment between business needs and technology capabilities in a global matrix setup.

This role emphasizes stakeholder engagement, solution evaluation, and adherence to quality, privacy, and regulatory standards, including GxP and CSV requirements, across end-to-end initiatives.

Qualifications

• 6-9+ years of experience as a Business Analyst, Functional Analyst, Product Analyst, or equivalent role supporting IT transformation.
• 4+ years of experience in pharmaceutical, biotechnology, healthcare, clinical research, quality, regulatory affairs, or medical affairs environments.
• Demonstrated expertise in requirements elicitation, process modelling, workshop facilitation, stakeholder management, and solution evaluation.
• Ability to translate complex business needs into clear solution specifications, user stories, acceptance criteria, process models, test scenarios, and decision materials.
• Strong stakeholder management, communication, workshop and requirements gathering facilitation, and influencing skills, including experience working with senior business and IT stakeholders.
• Working knowledge of GxP/CSV principles, regulated environments, data privacy, security, quality documentation, and applicable standards.

Responsibilities

• Plan and facilitate discovery workshops, interviews, and working sessions to define business objectives, scope, pain points, opportunities, risks, and success measures.
• Own the requirements lifecycle, including elicitation, analysis, prioritization, validation, approval, change control, and traceability.
• Translate business needs into clear, testable business, functional, non-functional, data, reporting, integration, security, and compliance requirements, producing fit-for-purpose deliverables including business requirements, user stories, acceptance criteria, process maps, workflows, use cases, functional specifications, and RFP inputs.
• Assess solution options and recommend approaches that balance business value, user experience, cost, timeline, risk, compliance, and technical feasibility.
• Analyse current-state and future-state processes and recommend opportunities for standardization, simplification, automation, data integration, and digital innovation.
• Assess business process and organizational impacts of proposed solutions and support change readiness activities.
• Partner with data and analytics teams to define critical data elements, business rules, data quality needs, and reporting or analytical requirements.
• Build trusted relationships with business stakeholders, IT teams, vendors, and partners across a global matrix organization.
• Embed GxP, CSV, quality, cybersecurity, privacy, and regulatory requirements into deliverables.
• Partner with Quality and CSV teams on risk assessments, validation planning, requirements traceability, UAT, and documentation.
• Ensure business requirements and traceability documentation are complete, approved, and audit-ready.
• Contribute to business case development, benefits identification, and scope definition.
• Share best practices and mentor junior analysts.

Skills

Stakeholder management

Requirements elicitation

Process modelling

Workshop facilitation

Documentation & traceability

Job description

Ipsen Pharma (SAS) seeks a Senior Business Analyst to partner with R&D, Medical, and IT to deliver compliant, scalable digital solutions. You will define and manage business requirements, analyze processes, and ensure alignment between business needs and technology capabilities in a global matrix setup.

This role emphasizes stakeholder engagement, solution evaluation, and adherence to quality, privacy, and regulatory standards, including GxP and CSV requirements, across end-to-end initiatives.