Top 3 Must Have Skill Sets:
• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• Independent time management and prioritization skills
• Critical thinking skills
*Veeva experience preferred
***Regulatory ops/ regulatory affairs preferred***
Job Details: All, or a subset of the following:
• Monitoring data quality/health, including collaboration with other internal functions to maintain planned submission and approval dates
• Updating the Regulatory Submissions and Document Information Management System (RSDIMS)
• Metrics compilation and analysis
• Liaison with internal customers to improve efficiencies within RDA and other functional areas
Manages requests within the Regulatory Intake System to comply with data management of a GMP system.
Bachelors degree and 2 YOE preferred
"This posting is for Contingent Worker, not an FTE"