Join our Team

We are currently hiring! Flexible hours and remote work are possible for full-time and part-time positions, upon completion of training. Signing bonus may be offered. To apply, please send your resume and cover letter to info@TruSubmit.com

eSubmissions Associate

• Associate's or higher degree is preferred
• Prepare electronic submissions using eCTDmanager to various Health Authorities (primarily US and EMA)
• Perform routing general formating and troubleshooting of complex MS Word documents
• Publish PDF files to a state of eCTD submission readiness using Adobe and additional add-ons (ISI toolbox)
• Ensure client specific archival and document transfer procedures are followed
• Highly organized with a phenomenal attention to detail

eSubmissions Manager

• Expert at electronic submissions publication PLUS:
• Determine submission requirements (specific QC parameters/job rules)
• High level project management including resourcing, setting timelines and delivering status updates to project team
• Active resource management: assign individual QC’s and eSubmissions assignments
• Oversee Quality System and QC processes for each submission
• Oversee and perform (as needed) associate level eSubs tasks including document level publishing, submission level publishing and document management/archiving
• Troubleshooting and Problem Solving of Submission and Document Level Publishing issues
• Experience with US and EMA submission
• Minimum of 3 years experience in Publishing or Regulatory Operations (5+ years preferred)

If you would like to learn more about a career in eSubmissions at TruSubmit, please send an inquiry or your resume and cover letter to info@TruSubmit.com.