Senior Veeva Business System Analyst

Replimune Limited - Woburn, MA

Full-time - Mid Level

Woburn, MA

About the position

The Senior Business System Analyst at Replimune will serve as the primary technical contact and systems owner for Veeva applications, focusing on compliance and efficiency within the GxP landscape. This role involves conducting needs and impact analysis, managing operational issues, and ensuring regulatory compliance while facilitating communication between stakeholders and Veeva. The position emphasizes the importance of understanding both the company's vision and compliance requirements to translate them into actionable objectives.

Responsibilities

• Maintain the validation state of Veeva GXP applications with appropriate change management.
• Manage all Veeva operational/technical issues to resolution.
• Facilitate and moderate Veeva governance and oversight working group.
• Attend Veeva events to stay informed of product developments and changes.
• Build working relationships with Veeva account managers and engineers.
• Develop working relationships with existing Veeva systems owners.
• Follow GxP process to ensure regulatory compliance for Veeva systems.
• Participate in internal audits as required.
• Plan, prioritize, monitor, facilitate, and manage multiple workstreams.
• Track and aid with resolution of technical issues.

Requirements

• Bachelor's degree in Computer Science, Information Technology, Business Administration, or a related field or equivalent practical experience.
• 3-5 years of experience in a similar role.
• Direct hands-on experience with Veeva GxP applications.
• Experience with 21 CFR 11 compliance.
• Experience implementing and managing Veeva vaults in a validated environment.

Nice-to-haves

• Strong written and oral communication skills.
• Service orientation, initiative, creativity, and organizational commitment.

Benefits

• Hybrid work environment with local candidates expected to be on-site 2 days per week.