Clinical Business Analyst

Title: Business Analyst 
Location: SFO,CA  - Remote (Locals only from CA)
Duration: Long  term
Experience: 9+ Years



Role Summary

We are seeking an experienced Business Analyst with strong domain knowledge in Clinical Content Management to support pharmaceutical product development. The role will focus on defining and implementing requirements for clinical content lifecycle automation, including Clinical Study Reports (CSR), regulatory documents, and protocol-related content.

Job description

• Collaborate with Clinical Development, Regulatory, Medical Writing, and Quality teams to understand business processes and pain points across the clinical content lifecycle.
• Demonstrate strong understanding of clinical documents such as:
• Clinical Study Reports (CSR)
• Protocols and protocol amendments
• Investigator Brochures (IB)
• Efficacy and safety sections
• Regulatory submissions (IND, NDA, BLA, CTA)
• Demonstrate Strong understanding of content processes including authoring, co-authoring, review, redlining, approval, submission, publishing, and archival.
• Demonstrate Strong understanding of Clinical content on traceability, auditability, version control, and compliance with regulatory guidelines (ICH, GxP, 21 CFR Part 11).

• Experience working with clinical content management platforms, such as:
• Veeva Vault (RIM / Quality / Clinical / MedComms)
• Documentum
• Define functional requirements for workflows, metadata models, templates, user roles, access controls, and document hierarchies.
• Support teams for optimization of content workflows to reduce cycle time and manual effort.

• Lead requirements gathering and documentation activities, including:
• Business Requirements Documents (BRD)
• Functional Requirements Specifications (FRS)
• User stories and acceptance criteria

• Contribute to initiatives focused on automation of Clinical Study Reports and associated workflows.

• Exposure to regulated environments (GxP, CSV, Part 11).
• Experience working with medical writers and regulatory affairs teams.
• Familiarity with Agile or hybrid delivery models.
• Prior experience in pharma R&D IT transformation or digital clinical initiatives.