Job Summary
An information technology company needs applicants for an opening for a Remote Clinical Research Regulatory Affairs Associate Specialist Manager in Morrisville.
Individual must be able to fulfill the following responsibilities:
- Provide regulatory and quality support
- Provide strategic regulatory guidance
- Support regulatory agency interactions
Required Skills:
- Ability to travel a minimum of 20% both domestically and internationally
- Bachelor's and 3 years experience or equivalent level of education and work experience
- 2+ years experience in regulatory affairs, quality assurance, and clinical research
- Knowledge of and familiarity with 21CFR11 and EDC systems
- Experience in preparation of audit plans and checklists against applicable standards
- Computer literate at a level allowing utilization of event tracking programs
