Business Analyst

Job Title: Business Analyst – Clinical Content Management Location: Remote Role Summary: We are seeking an experienced Business Analyst with strong expertise in Clinical Content Management to support pharmaceutical product development, focusing on clinical content lifecycle and automation. Primary Skills (Must Have): Clinical Development, Regulatory, Medical Writing, and Quality collaboration Clinical Study Reports (CSR) and regulatory documents Veeva Vault (RIM / Quality / Clinical / MedComms) or Documentum Clinical content lifecycle (authoring, review, approval, submission, archival) Regulatory compliance (ICH, GxP, 21 CFR Part 11) Job Description: Work closely with cross-functional teams to gather and analyse business requirements across the clinical content lifecycle Handle clinical documents such as CSR, protocols, IB, and regulatory submissions (IND, NDA, BLA, CTA) Define functional requirements, including workflows, metadata, templates, and access controls Support automation and optimisation of content processes to improve efficiency Prepare BRD, FRS, user stories, and acceptance criteria Ensure compliance with regulatory standards and audit requirements Collaborate with medical writing and regulatory teams in Agile or hybrid environments Preferred: Experience in pharma R&D or digital transformation initiatives Exposure to GxP, CSV, and regulated environments Apply / Refer: Abhi Jr IT Recruiter | S4 Analytics Phone: +1 (469)429-8068 Email: Abhi@s4analytix.com