Mgr, Reg & Start Up (FSP)
On-siteMexico City, Mexico City, Mexico
Job Summary
Oversee site activation and maintenance for selected studies, managing pre-award activities, scope of work, and budgets to meet project timelines. Develop and maintain the Management Plan while resolving issues and ensuring collaboration across Regulatory and Site Activation teams. Direct staff delivery, assign resources based on experience, and monitor quality metrics through regular reporting. Identify performance risks, create corrective action plans, and lead hiring reviews and onboarding. Requires a Bachelor's degree, 5-7 years of regulatory experience, and fluent English. IQVIA accelerates medical treatment development to improve patient outcomes globally.
Required Qualifications
- Bachelor's Degree
- Scientific discipline or health care
- 5 -7 years of prior relevant experience
- Submissions to regulatory entity and ethics committees
- local regulatory processes
- knowledge and use of DIGIPRiS
- knowledge and handling of ICFs
- preparation of risk analyses and projections
- interaction with and knowledge of the local Ministry of Health
- Proven ability to manage a team
- work alongside others in a global environment
- deliver results whilst meeting quality and timeline metrics
- Fluent English (read, spoken, and written)
- Provides others with a clear direction
- delegates work appropriately and fairly
- motivates, and empowers others
- monitors/manages performance
- provides feedback and coaching
Desired Qualifications
- Master's degree
- Experience with Start Up (FSP)
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