KellyMitchell matches the best IT and business talent with premier organizations nationwide. Our clients, ranging from Fortune 500 corporations to rapidly growing high-tech companies, are exceptionally served by our 1500+ IT and business consultants. Our industry is growing rapidly, and now is a great time to launch your career with the KellyMitchell team.
- Chron files, filing and updates
- Support Annual reports (IND and NDAs; N=70)
- Support for preparation, follow-up for PADERS, PSURs
- Minor labeling updates, PSN approvals, represent Regulatory on the Commercial label update team
- Participate/manage minor supplements and amendments
- Support HA correspondence
- F/U with Orange Book entries
- Other regulatory projects
- Bachelor’s degree in scientific field
- Two years of pharma experience and/or medical devices.
- Have scientific experience
- Need to communicate well
- Work in a cross-functional matrix environment
- Feel comfortable presenting
- Tech Savvy Systems database repository experience, need to be able to learn quickly