Senior Business Analyst / Lead

Position Overview

We are seeking a Senior Business Analyst / Lead with PMP certification to support the client. This role will lead business analysis efforts, drive process improvements, and serve as the primary liaison between FDA stakeholders and technical teams.

The ideal candidate will have strong experience in federal environments, regulatory processes, and user support operations, with the ability to manage complex workflows and mentor junior analysts.

Key Responsibilities

Leadership & Stakeholder Management

• Lead and mentor a team of Business Analysts supporting operations
• Act as the primary point of contact for FDA stakeholders, including program managers and end users
• Facilitate workshops, stakeholder meetings, and requirements sessions

Business Analysis & Process Improvement

• Analyze current-state business processes and identify gaps, inefficiencies, and risks
• Design and document future-state workflows aligned with FDA regulatory requirements
• Develop process maps, SOPs, and business requirement documents (BRDs/FRDs)

User Support & Operations

• Oversee Tier 2/3 user support for regulatory and business systems
• Ensure timely resolution of user issues and service requests
• Develop training materials and conduct user training sessions

Project & Program Management

• Apply PMP-based methodologies to manage scope, timelines, and deliverables
• Coordinate cross-functional teams including IT, QA, and compliance
• Track progress, risks, and dependencies; provide regular status reports

Compliance & Documentation

• Ensure all processes and documentation meet federal and FDA compliance standards
• Maintain audit-ready documentation and support regulatory reviews

Required Qualifications

• PMP Certification (from Project Management Institute) – Required
• 8+ years of experience as a Business Analyst, with 3+ years in a lead role
• Experience supporting federal clients or regulated environments (FDA, healthcare, pharma preferred)
• Strong expertise in:
  • Business process modeling (BPMN, Visio)
  • Requirements gathering & documentation
  • Stakeholder engagement
• Experience with tools such as ServiceNow, Jira, SharePoint, and MS Office Suite
• Excellent communication and leadership skills

Preferred Qualifications

• Prior experience with CDER or FDA programs
• Knowledge of regulatory submission processes or compliance frameworks
• Experience in user support / helpdesk operations within federal systems
• Agile / Scrum experience is a plus

Key Competencies

• Strategic thinking and problem-solving
• Ability to manage multiple priorities in a regulated environment
• Strong documentation and process standardization skills
• Leadership and team mentorship

Why Join This Project

• Long-term federal program with high impact on public health
• Opportunity to work with mission-critical FDA systems and processes
• Stable, compliance-driven environment with structured growth