Senior Software Engineer

Veeva Publishing SME

Role

Veeva Publishing specialist/ Veeva RIM Specialist.

Mandate to be Certified Veeva Vault Platform Certified Administrator

Responsibilities

• Publish regulatory submissions using Veeva Vault RIM or other Veeva Vault applications (e.g., Vault Submissions, Vault Submissions Archive).
• Support document preparation, formatting, hyperlinking, bookmarking, and validation for regulatory submissions (e.g., IND, NDA, CTA, 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 (e.g., ESG, EMA Gateway).
• Knowledge of submission lifecycle from authoring to archival. GxP and 21 CFR Part 11 compliance experience.