Job Summary
A clinical research organization has an open position for a Remote Regulatory Project and Submission Manager.
Individual must be able to fulfill the following responsibilities:
- Partner with document providers to project manage the timely receipt of submission ready documents for inclusion in global dossiers
- Project manage submission related operational aspects and creates and manages project plans for regulatory projects
- Lead project execution strategy plans from initiation to closeout
Must meet the following requirements for consideration:
- 8 years of relevant experience
- Bachelor's degree in relevant field of study
- Strong understanding of document management systems and concepts
- In-depth knowledge of the drug development process
- Advanced knowledge of review and approval processes of applicable regulatory agencies
- Skilled in interpretation and utilization of applicable technologies