Business Analyst

Job Title: Business Analyst – Clinical Content Management Location: Remote Industry: Pharmaceutical / Life Sciences Job Summary We are seeking an experienced Business Analyst with expertise in Clinical Content Management to support pharmaceutical product development and digital initiatives. The role involves working with cross-functional teams to improve and automate clinical documentation and content lifecycle processes. Key Responsibilities • Collaborate with Clinical, Regulatory, Medical Writing, and Quality teams to understand business needs. • Gather and document requirements (BRD, FRS, user stories). • Support automation of Clinical Study Reports (CSR) and regulatory documentation workflows. • Define workflows, metadata, document hierarchies, and access controls. • Optimize content lifecycle processes and ensure regulatory compliance. • Work in Agile or hybrid project environments. Required Expertise • Strong knowledge of clinical documents such as CSRs, Protocols, Investigator Brochures, and regulatory submissions (IND, NDA, BLA, CTA). • Understanding of content lifecycle processes including authoring, review, approvals, publishing, archival, and version control. • Experience in Pharma or Life Sciences environments. • Knowledge of ICH guidelines, GxP, and 21 CFR Part 11 compliance. • Hands-on experience with Veeva Vault and OpenText Documentum. • Strong communication and documentation skills. Preferred • Experience in Pharma R&D IT or digital clinical transformation initiatives. Apply / Refer: Abhi Jr IT Recruitment | S4 Analytics Phone: +1 (469)429-8068 Email: Abhi@s4analytix.com