Regulatory Operations Publisher

Job Description

Regulatory Operations Publisher

The Regulatory Operations Publisher will serve as an internal team member for electronic submission publishing projects, primarily in eCTD format. He/she will collaborate with colleagues and clients on routine, project related matters. The Regulatory Operations Publisher will be responsible for completing tasks assigned in order to support team members in meeting submission deadlines.

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
• Learn more about our core values here!
  
  

• Bachelor’s degree or equivalent experience
• Strong computer skills, including proficiency with MS Office and Microsoft Word functionality in terms of formatting documents using content templates or MS Word styles
• 0 - 3 years of prior experience using software applications including Adobe Acrobat and MS Office working in a professional environment that demands high utilization of computer and communication skills
• Technical knowledge of US, CA and EU eCTD submission requirements or willingness to learn
• Excellent IT/computer skills
• Excellent written and verbal communication skills
• Ability to compile regulatory submissions with supervision by team leaders
• Work in a role that demands strong attention to detail and organizational skills in a fast-paced environment
• Use simple rules, common sense and experiences to identify issues in the work product