Seagen

IT System Analyst - Vault Clinical/Regulatory Suite

Description

Summary:

The IT Systems Analyst – Veeva Clinical/Regulatory Suite is a key member of the IT Business Solutions team and is responsible for deploying, configuring, implementing validated technology systems at Seattle Genetics; acting as subject matter expert where appropriate; and providing ongoing process and enhancement support post-implementation for Veeva Vault and other associated Clinical and Regulatory Systems.

Principal Responsibilities:

• Responsible for the implementation and ongoing support of validated IT applications, including on-prem server-based applications, laboratory systems, and SaaS solutions
• Design and implement cloud-based integrations
• Taking complex client and Technical concepts and articulating them to audiences of varying perception levels
• Drive the implementation of the technical strategy from architectural authority
• Set up architecture and design documentation for solutions in their area
• Provide technical leadership to a team delivering software solutions & release deployments
• Complete upgrades and enhancements to existing applications
• Requisition application servers and assist in application installation
• Participate in GxP validation/qualification of systems including writing, reviewing, and executing validation protocols
• Create user documentation and train personnel on applications /reports /solutions, as required
• Author and refine system support processes, flow diagrams, configurations, and interdependencies
• Develop effective working relationships with our internal customers and vendors during project meetings, on-site visits, and conference calls
• Act as the customers trusted advisor to ensure that the custom Technical is configured in such a way that it meets the customer's goals and offers the full benefits of Veeva’s Clinical or Regulatory application
• Manage the application integrations across Vault Clinical & Regulatory Suite

Additional responsibilities for Sr. System Analyst:

• Ability to articulate integration design patterns
• Experience with GxP regulations and software validation process
• Notify project management of project risks and develop contingency plans, as necessary
• Ensure customer success from beginning to end of the project life cycle

Qualifications:

• Experience in supporting and implementing large scale IT solutions
• Experience supporting a Veeva Vault system, specifically, Veeva Clinical & Regulatory suite
• Provide subject matter expertise on the Veeva Systems implementation, Vault R&D product suite, Vault Platform, technical design, and Software as a Service (SaaS) implementation best practices
• Experience building solutions and interfaces in cloud, SaaS applications using REST APIs
• Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation
• Provide subject matter expertise on the Veeva Vault product functionality and APIs
• Proven knowledge of IT solutions and application management through various product cycles and business environments
• Ability to prioritize and quickly adapt to changing situations
• Strong interpersonal skills, with a high degree of self-motivation and ability to work independently

Additional qualifications for Sr. System Analyst:

• Demonstrated technical understanding of application architecture to include application servers, web servers, configuration files, relational databases, SQL, and reporting applications
• Has a great understanding and thorough knowledge on System Architecture, Integration and Master Data management

Preferred:

• Veeva Vault certification
• Familiarity with biotech/pharma business processes and applications
• Familiarity with GxP and ICH regulations and 21CFR, Part 11

Education and Experience:

• 3+ years’ experience with master’s degree (5+ for Sr.System Analyst) or 5+ years of experience with bachelor’s degree (8+ for Sr.System Analyst) in Business, Computer Science, Engineering or related discipline, or equivalent work experience

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/19/2021