Senior IT Business Systems Analyst - Regulatory

Role Summary

The IT Business Systems Analyst acts as a strategic technology business partner to support and implement innovative process and system improvements to promote overall organizational efficiency and effectiveness, with a focus on Regulatory systems. This role ensures documentation of business requirements and business process definitions; systems consulting; and systems support management. This individual will provide oversight and continuity of the detailed system processes and configurations within and across software applications used at Apellis.

Responsibilities

• Collaborate with business stakeholders to understand, define, and document business processes and functional requirements
• Represent IT as a business analyst and technical SME, analyzing business needs, and identifying solutions that align to strategic goals
• Review, analyze, and evaluate business systems for their applicability to identified user needs
• Develop and maintain documentation for functional requirements and detailed business system processes
• Manage and coordinate support activities and incident resolution across internal teams and external personnel, including managed services vendor(s)
• Troubleshoot procedural, operational and configuration issues, and proactively document process improvements
• Ensure IT compliance by collaborating with Quality Validation and business stakeholders on computer system validation (CSV) and regulatory requirements (GxP)

Skills

• Thorough knowledge of Regulatory operations and related business functions, including Submissions, Publishing (Gateway,eCTD), and Labeling
• Customer Service oriented with a keen attention to detail and quality
• Ability to be empathetic to business user needs, and seeing things from their perspective
• Team-oriented and generous in sharing knowledge and enabling others
• Reliable, consistent, and proactive
• Capable of day-to-day problem solving and taking responsibility for decisions
• Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities
• Strong verbal and written communication skills
• Ability to communicate and work with cross-functional/inter-departmental teams and within the framework of the IT organization, as well as to work independently
• Proficient in Microsoft Word, Excel, PowerPoint and other applications

Experience

• Experience with business process development and gap analysis, as well as business process mapping efforts
• Experience designing, deploying, and maintaining cloud-based applications
• Experience working in a GxP environment, including change control, change management, Computer Software Validation (CSV)
• Experienced in working with software vendors for support and maintenance
• Bachelor‚Äôs degree in computer science, technology, operations, or related disciplines required
• 5+ years in a pharmaceutical/biotech or related environment required
• Highly desired:
  • Experience with Veeva Vault (RIM Submissions, Submissions Archive, and Registrations)
  • Experience with IQVIA RIMSmart