Veeva Submission SME

Job Description

Role: Veeva Publishing Specialist / Veeva RIM Specialist

Responsibilities

• Publish regulatory submissions using Veeva Vault RIM or other Veeva Vault applications, such as Vault Submissions and Vault Submissions Archive.
• Support document preparation, formatting, hyperlinking, bookmarking, and validation for regulatory submissions, including IND, NDA, CTA, and MAA.
• Ensure submission packages meet applicable eCTD standards and global regulatory requirements.
• Collaborate with Regulatory Affairs, Regulatory Operations, and Document Management teams to ensure submission readiness.
• Maintain submission trackers, timelines, and communication logs within Veeva.
• Provide technical support for Veeva Vault publishing tools and workflows.
• Participate in publishing process optimization and ensure compliance with SOPs and GxP guidelines.

Skills Required

Experience and certification with Veeva Vault RIM or Veeva Submissions is required.

Preferred Skills

• Familiarity with health authority portals, such as ESG and EMA Gateway.
• Knowledge of the submission lifecycle from authoring to archival.
• Experience with GxP and 21 CFR Part 11 compliance.