IT Business Systems Analyst - Saxon Global : Job Details

Company: Apellis Pharmaceutical Title: IT Business Systems Analyst Location: 100 5th Ave, Waltham, MA 02451 - 100% remote Duration: 6 Months w/possible extensions Visa: No H1 Rate:$65/hr. on C2C Senior Role - must have 10+ years of experience - Very strong with Veeva Vault ApplicationsCandidates MUST Have:

• Recent strong Veeva Vault Experience
• Strong Systems background
• 10+ years of experience
• Experience in supporting one or more Veeva Vault Applications: Clinical (eTMF, CTMS), RIM (Submissions, Registrations), Quality (QDocs, QMS). Veeva Vault Administration Certification is required (i.e. Platform White Belt or higher/specific).
• Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC

IT Business Systems Support Analyst, Veeva Vault Application Support 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 individual will be responsible for:

• functional requirements and documentation of detailed business system processes
• impact assessments of changes, both system and overall end-to-end processes, including data integrations, system to system integrations or Vault to Vault integrations (including cross-links, connectors) where applicable
• workflow scenario (positive and negative) testing, including technical and end user testing
• application configuration, deployment and documentation, computer system validation documentation
• system support management, including coordination of application configurations performed by service and support vendor(s)
• support and promote an iterative, incremental system enhancement and maintenance methodology, optimizing the vendor's platform releases along with Apellis application release schedule
• end user support, which may include report and dashboard development

This individual will report to the IT Business Systems Manager and will work across the IT Business Systems Team. Key Responsibilities:

• Coordinates support activities across internal and external personal, including managed services vendor(s).
• Identify and troubleshoot procedural, operational and configuration issues.
• Provide IT system support, including vendor operational and maintenance and oversight to the vendor's SLAs.
• Leverages standard best practices for multi-tenant web-based solutions and IT Computer System Validation artifacts:
  • Participates in impact assessments, user requirements and functional specifications, test scripts, and the review of any test or validation plans and corresponding summary reports
  • Provides supporting artifacts to computer system validation and change control documentation including Platform Releases and Vault Application Releases

Skills, Knowledge & Abilities:

• Self-motivated and passionate to learn and adopt new technology and methodologies
• 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
• Customer Service oriented with attention to detail and quality
• 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 independently with cross-functional/inter-departmental teams and within the framework of the IT organization.
• Proficient in Microsoft Word, Excel, PowerPoint and other applications.

Experience:

• Experience in supporting one or more Veeva Vault Applications: Clinical (eTMF, CTMS), RIM (Submissions, Registrations), Quality (QDocs, QMS). Veeva Vault Administration Certification is required (i.e. Platform White Belt or higher/specific).
• Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC
• Experience working in a GxP environment(s) (FDA, EU, MHRA) is required. Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6.
• Bachelor's degree in computer science, technology, operations, or related disciplines required.
• 5+ years in a pharmaceutical/biotech or related environment required