What You’ll Do

• Utilize best practices to support Vault Submissions Publishing deployment projects,
• Ensure continued customer success post-implementation,
• Gain an in-depth understanding of Publishing use cases (eCTD, non-eCTD, Paper, Device) and how the Vault Submissions Publishing application aligns with those use cases,
• Work collaboratively with the product team to pass on customer feedback regarding use cases and requests for product improvement.

Requirements

• Minimum of 4 years of pharmaceutical industry, regulatory publishing/submissions management experience,
• Technologically savvy with the ability to quickly learn software applications and troubleshoot as needed,
• Fluent understanding of regulatory submission processes and requirements including eCTD publishing principles and lifecycle management,
• Working knowledge of health authority regulations and industry standards of regulatory operations,
• Experience working with EU and US Regulatory Agencies supporting Regulatory Dossier review and approval processes,
• Excellent skills in oral and written communications, integrity, and adaptability,
• Ability to work independently in a dynamic environment,
• Ability to travel up to 40%

Nice to Have

• Direct experience with systems such as Veeva Vault or other submission publishing systems,
• Consulting experience, working with a major system integrator or software vendor,
• Regulatory Affairs, Regulatory Operations or Pharmacovigilance background,
• Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data, and content,
• Life Science, computer science, or related degree,
• SaaS/Cloud experience.