Ctry Approval Spec

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.
**Essential Functions and Other Job Information**:
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local SIA services and coordination of these projects.
- May have contact with investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPD’s target cycle times for site.
- May work ...