IT BA - Veeva Vault Admin

MUST HAVE

VEEVA VAULT APPLICATION SUPPORT EXPERIENCE - Clinical, Quality, RIM

BUSINESS ANALYSIS

This position, IT Business Systems Support Analyst, will support several Veeva Vault Applications across the Apellis’ Development Vault Platform. This individual will be responsible for the application administration and support across the following Veeva Vault Development Application Suites: Clinical, Quality, RIM. This individual will provide oversight and continuity of the detailed system processes and configurations within and across the Veeva Vault Applications used at Apellis.

This position will be 100% remote. Please include the candidates’ birth day and month and the last 3 SSN.

Title: IT Business Systems Analyst

IT Business Analyst – TEMP

Location: Waltham MA, Open to both fully remote and hybrid candidates (local candidates ideal, or EST and CT time zones only please.) Must be able to work EAST COAST Times (the occasional 8am EST meetings may occur to overlap with Europe).

Minimum 6-month contract – Perm is a future possibility based on business needs and performance.

Position Summary

The role will be responsible for gathering GxP and non GxP business requirements, business process definition/documentation, SaaS systems consulting, and system support management. Position will focus on business process documentation and business requirements, implementing and supporting Regulatory and Clinical business solutions.

Key Responsibilities

• Identify and troubleshoot operational issues and system issues.
• Document business needs and identify solutions that align to overall business strategies. Review, analyze, and evaluate business systems for their applicability to identified user needs.
• Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts. Executes and facilitates GxP Computer System Validation activities for IT, including implementation, validation, maintenance.
• Responsible for CSV documentation including System Assessments, Validation Plan, User Requirements and/or Specifications, Testing Protocols and Scripts (UAT), Traceability Matrix, Validation Summary Report, etc.
• Support and maintain procedures and operational support processes.
  

Skills, Knowledge & Abilities

• Customer Service oriented with attention to detail and quality.
• Reliable, consistent, proactive and accountable, adaptable to changes.
• SaaS IT systems configuration or software quality assurance background
• Ability to effectively collaborate as part of a team yet can also work independently.
• Problem solving skills.
• Must be able to effectively prioritize and plan.
• Strong communication and facilitation skills to develop consensus, clarity, and decision-making.
• Understanding of technical IT issues to enable discussions with internal and external technical specialists.
• Experience working in a GxP environment(s) is required, including change control, change management, CSV
  
  

Experience

• Experience with business process development and gap analysis, and business process mapping efforts.
• Experience with Regulatory Systems and eCTD Submissions is highly preferred.
• Bachelor’s degree in computer science, technology, operations, or related disciplines required.
• 5+ years in a pharmaceutical/biotech or related environment required.