Remote Clinical Research Regulatory Affairs Associate Specialist Manager in Morrisville

Job ID: Available for Members

Location: North Carolina

Compensation: To Be Discussed

Staff Reviewed: Thu, Apr 02, 2020

Job Category: Healthcare, Legal

Telecommute Level: Occasionally

Travel Requirements: Field Travel Required, Some Travel

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced

Additional Information: Benefits Available

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