Piper Companies is seeking a Business Analyst to support a global regulatory transformation initiative within a leading pharmaceutical organization. This individual will partner with Regulatory Affairs, Regulatory Operations, and business stakeholders to support process improvements, requirements documentation, system-related initiatives, and project delivery efforts.
Responsibilities of the Business Analyst:
- Facilitate requirements gathering sessions and workshops with Regulatory Affairs, Regulatory Operations, and cross-functional stakeholders.
- Gather, document, validate, and manage business and functional requirements.
- Create and maintain Business Requirements Documents (BRDs), process flows, and project documentation.
- Partner with business SMEs to define and document current-state and future-state business processes.
- Support business process improvement and transformation initiatives across regulatory functions.
- Coordinate and support User Acceptance Testing (UAT), including test planning, execution support, and issue resolution.
- Act as a liaison between business stakeholders, process owners, and technical teams while supporting change management activities.
Qualifications of the Business Analyst:
- 6+ years of experience supporting business analysis, regulatory operations, regulatory systems, or transformation initiatives within pharmaceutical, biotech, CRO, or life sciences environments.
- Strong understanding of Regulatory Affairs, Regulatory Operations, regulatory submissions, or related pharmaceutical business processes.
- Proven experience facilitating workshops, gathering requirements, and managing stakeholder relationships.
- Experience developing process documentation, business requirements, workflows, and process maps.
- Hands-on experience supporting system implementations, technology initiatives, or software delivery projects.
- Experience supporting User Acceptance Testing (UAT), validation activities, and issue resolution.
- Experience with Regulatory Information Management (RIM) platforms, regulatory systems, or Veeva Vault RIM is highly preferred.
Compensation for the Business Analyst:
- Salary Range: $80,000 - $90,000
- Comprehensive benefits package including medical, dental, vision, 401(k), and PTO
- Remote
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Keywords:
Business Analyst, Regulatory Affairs, Regulatory Operations, Regulatory Information Management, RIM, Regulatory Systems, Veeva Vault, Veeva Vault RIM, Requirements Gathering, BRD, Business Requirements Documents, Process Mapping, Business Process Improvement, UAT, User Acceptance Testing, Stakeholder Management, Change Management, Regulatory Submissions, IND, NDA, CTA, eCTD, Pharmaceutical Industry, Biotech, CRO, Life Sciences, Regulatory Transformation, SDLC, Functional Analyst, Systems Analyst, Regulatory Information Systems, Regulatory Data Management.
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