Sr. Business Analyst – AI Enablement (Pharma Experience Required)

Job Title: Sr. Business Analyst – AI Enablement (Pharma Experience Required)

Location: Remote (EST Time Zone Preferred)

Job Summary

We are seeking an experienced Senior Business Analyst – AI Enablement to drive AI and automation initiatives within a clinical-stage pharmaceutical environment. The ideal candidate will partner with business stakeholders to identify, evaluate, and implement AI-powered solutions that improve operational efficiency, compliance, and business outcomes while adhering to regulatory requirements.

Key Responsibilities

• Collaborate with business leaders and cross-functional teams to identify opportunities for AI, automation, and process optimization.
• Analyze current-state workflows, business processes, and operational challenges to uncover high-value AI use cases.
• Assess and prioritize AI initiatives based on business impact, feasibility, cost, risk, and implementation complexity.
• Gather, document, and translate business requirements into detailed functional specifications for technical teams and vendors.
• Facilitate communication between business stakeholders, data teams, AI engineers, and technology partners.
• Develop process maps, workflow diagrams, user stories, business cases, and project documentation.
• Lead proof-of-concept (POC) initiatives and pilot programs using AI technologies, including Generative AI, Machine Learning, Document Intelligence, and Process Automation solutions.
• Define KPIs, success metrics, and performance measurements to evaluate AI solution effectiveness and ROI.
• Partner with IT, Quality Assurance, Regulatory Affairs, and Compliance teams to ensure adherence to GxP, 21 CFR Part 11, ALCOA+, data privacy, and AI governance standards.
• Support change management activities, including user training, process documentation, adoption planning, and stakeholder engagement.
• Provide ongoing recommendations for continuous process improvement and AI innovation across business functions.

Required Qualifications

• 8+ years of Business Analysis, Process Improvement, Management Consulting, or related experience.
• Prior experience within Pharmaceutical, Biotechnology, Life Sciences, or other highly regulated industries.
• Proven experience identifying, evaluating, and implementing AI, Machine Learning, RPA, Analytics, or Generative AI solutions.
• Strong expertise in business process mapping, requirements gathering, workflow analysis, and solution assessment.
• Experience with tools such as Jira, Visio, Lucidchart, Confluence, and Business Intelligence platforms.
• Excellent stakeholder management, communication, and presentation skills.
• Ability to work independently in fast-paced environments with evolving priorities.

Preferred Qualifications

• Working knowledge of Pharmaceutical functions including:
  • Clinical Operations
  • Regulatory Affairs
  • CMC / Manufacturing
  • Pharmacovigilance
  • Medical Affairs
  • Commercial Operations
• Understanding of GxP regulations, ALCOA+, Data Integrity principles, and 21 CFR Part 11 compliance.
• Familiarity with AI Governance, Responsible AI, and Risk Management Frameworks.
• Hands-on experience with LLM-based tools (ChatGPT, Copilot, Gemini, Claude), Prompt Engineering, or Low-Code/No-Code Automation Platforms.
• Experience supporting AI adoption, organizational change management, and digital transformation initiatives.

Required Skills

• Business Analysis
• AI Enablement
• Generative AI
• Process Improvement
• Pharma / Life Sciences
• Requirements Gathering
• Workflow Mapping
• AI Governance
• GxP Compliance
• Jira
• Visio
• Lucidchart
• Change Management
• Stakeholder Management