Senior/Lead Business Analyst - Pharma GxP

EPAM is a leading global provider of digital platform engineering and development services. We are committed to having a positive impact on our customers, our employees, and our communities. We embrace a dynamic and inclusive culture. Here you will collaborate with multi-national teams, contribute to a myriad of innovative projects that deliver the most creative and cutting-edge solutions, and have an opportunity to continuously learn and grow. No matter where you are located, you will join a dedicated, creative, and diverse community that will help you discover your fullest potential.

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

We offer
• Opportunity to work on technical challenges that may impact across geographies
• Vast opportunities for self-development: online university, knowledge sharing opportunities globally, learning opportunities through external certifications
• Opportunity to share your ideas on international platforms
• Sponsored Tech Talks & Hackathons
• Unlimited access to LinkedIn learning solutions
• Possibility to relocate to any EPAM office for short and long-term projects
• Focused individual development
• Benefit package:
• Health benefits
• Retirement benefits
• Paid time off
• Flexible benefits
• Forums to explore beyond work passion (CSR, photography, painting, sports, etc.)