-
Business Analyst, Submission Planning (Veeva…
- Insight Global (Upper Gwynedd, PA)
-
Job Description
A large pharmaceutical company is seeking an experienced Business Analyst to support the ARC (Accelerate Regulatory Capabilities) project focused on Veeva Submissions and Registration. This role is critical in planning and mapping regulatory submission processes to Veeva best practices.
Key Responsibilities:
• Lead submission planning across multiple markets (e.g., RDA start, PSPM planning) within Veeva.
• Analyze current processes and define how they will transition into Veeva, including writing user stories, success criteria, and configuration requirements.
• Collaborate with content management teams on authoring workflows and templates (eCTD Modules 1–5).
• Ensure alignment between planning and content components in Veeva Submission Vault.
• Utilize JIRA for tracking requirements and progress.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
• 3–5+ years of Business Analysis experience in Life Sciences or Regulatory Affairs.
• Hands-on experience with Veeva Vault RIM Submissions, with demonstrable experience implementing or configuring Submission Content Planning (Content Plans, plan items, commitments, milestones).
• Familiarity with regulatory submission types (eCTD, IND, NDA, ANDA).
• Strong skills in requirements elicitation, process mapping, user story writing, and acceptance criteria definition.
• Experience with system migration, UAT, validation, and training delivery.
• Strong stakeholder engagement, communication, and workshop facilitation skills. • Understanding of integration points between Veeva RIM and other Vaults (Clinical, Safety, Quality).
• Prior involvement in large enterprise transformation programs.
• JIRA experience
-
Recent Jobs
-
Business Analyst, Submission Planning (Veeva migration)
- Insight Global (Upper Gwynedd, PA)