Senior/Lead Business Analyst - Pharma GxP
We are seeking a Senior/Lead Business Analyst to join our Pharma R&D team, focused on content management and knowledge management initiatives. The ideal candidate will bring strong expertise in dossier submission, structured content authoring, content auto-generation and auto-stitching to support enterprise-wide R&D transformation.
Responsibilities
- Define and manage business requirements for enterprise content management (ECM) platforms within R&D
- Collaborate with cross-functional stakeholders to govern content lifecycle including creation, review, approval and archival
- Support migration, integration and optimization of content repositories aligned to regulatory standards
- Drive requirements for electronic Common Technical Document (eCTD) and dossier submission workflows, working with regulatory affairs and CMC teams to ensure content readiness for global health authority submissions
- Translate regulatory content standards (ICH, FDA, EMA) into system and process requirements
- Lead business analysis for DITA or XML-based structured authoring implementations, including content templates, taxonomies and metadata schemas for reusable modular content
- Facilitate workshops with medical writers and regulatory professionals on structured authoring adoption
- Gather and document requirements for AI/ML-driven content auto-generation capabilities and define workflows for automated content stitching
- Partner with data science and engineering teams to validate auto-generated content quality and compliance
- Design knowledge management frameworks to capture, classify and surface institutional knowledge within R&D, including KPIs, governance, ontologies and taxonomy structures
- Conduct gap analyses, as-is/to-be process mapping and user story creation while managing backlog, sprint planning and UAT coordination in Agile/SAFe delivery models
- Serve as liaison between business stakeholders, IT architects and development teams
Requirements
- 6-15 years of professional experience as a Business Analyst, preferably within Pharma R&D
- Hands-on expertise in ECM/CMS platforms such as Veeva Vault, OpenText or SharePoint
- Knowledge of eCTD structure, regulatory submission lifecycle and ICH guidelines
- Familiarity with DITA and XML-based authoring tools (Arbortext, Oxygen XML or similar)
- Experience gathering requirements for AI/NLP-based content generation tools or platforms
- Understanding of automated document assembly, template engines and modular content workflows
- Proficiency in BRD, FRD and user stories, with skills in process mapping (BPMN) and use-case documentation
- Background in Agile or SAFe delivery environments using JIRA and Confluence
- Understanding of pharmaceutical R&D processes, GxP and regulatory compliance
- Strong facilitation, workshop management and presentation skills
