Business Analyst

Job Title: Business Analyst – Clinical Content Management Location: Remote Role Summary We are looking for an experienced Business Analyst with deep expertise in Clinical Content Management to support pharmaceutical product development initiatives. The role focuses on clinical document lifecycle automation, regulatory compliance, and content workflow optimization. Primary Skills (Must Have) • Strong domain expertise in Clinical Content Management • In-depth knowledge of clinical documents: • Clinical Study Reports (CSR) • Protocols & Amendments • Investigator Brochures (IB) • Regulatory submissions (IND, NDA, BLA, CTA) • Hands-on experience with clinical content lifecycle processes: • Authoring, co-authoring, review, approval, publishing, archival • Expertise in regulatory compliance & standards: • ICH, GxP, 21 CFR Part 11 • Experience with clinical content platforms: • Veeva Vault (RIM / Clinical / Quality / MedComms) • Documentum • Strong understanding of: • Traceability, auditability, version control • Ability to define: • Workflow processes • Metadata models • Templates & document hierarchies • User roles & access controls Key Responsibilities • Collaborate with Clinical Development, Regulatory, Medical Writing, and Quality teams • Gather and document requirements (BRD, FRS, user stories) • Analyze and optimize clinical content workflows to improve efficiency • Support automation initiatives for Clinical Study Reports (CSR) • Ensure compliance with regulatory and validation requirements • Work closely with stakeholders to translate business needs into technical solutions Preferred Skills • Experience in pharma R&D IT transformation or digital clinical initiatives • Exposure to GxP, CSV environments • Experience working with medical writers & regulatory teams • Familiarity with Agile or hybrid delivery models Navya Marripudi IT Lead Recruiter | S4 Analytics navya@s4analytix.com +1 (551) 300-0477 Ext.108