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.
TruSubmit, LLC
Denver, Colorado 80238
(720) 746-1190 Tel
(720) 746-1192 Fax
info@TruSubmit.com