Clinical Trial Reg Affairs Specialist III
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
- Supports the preparation of documentation and submissions under EUCTR guidance.
- Coordinates and manages client deliverables supporting regulatory compliance.
- Liaises with internal and external clients in the tracking and status update ofproject plans and overall support of projects.
- Maintains knowledge and understanding of SOPs client SOPs/directives andcurrent regulatory guidelines.
- Evaluates client needs in relationship to overall project timelines quality anddelivery.
- Engages with other project team members functional units and/or management asnecessary to deliver final product and resolve/mitigate identified issues orbarriers to delivery as needed
- Provides project specific services documentation and coordination of projects and supports reporting of same to management internal and external clients.
- Supports preparation of bids and proposals; generates tracks and analyses data for proposal revisions contract modifications and bid defenses.
Education and Experience:
Bachelors or masters degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 4 years)
Required Experience:
IC
Key Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more