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Country Approval Specialist
hace 1 mes
CAS:
As PPD CAS, the following will be the responsabilities:
- Prepares, reviews and coordinates, under guidance, local regulatory submissions
therapy approvals, viral safety dossiers, import license) in alignment with global
submission strategy.
- 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 with the start-up CRA(s) to prepare the regulatory compliance review
packages, as applicable.
- May develop country specific Patient Information Sheet/Informed Consent form
documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Supports the coordination of feasibility activities, as required, in accordance with
agreed timelines.
- Entes and maintains trial status information relating to SIA activities onto PPD
tracking databases in an accurate and timely manner.
- Ensures the local country study files and filing processes are prepared, set up
and maintained as per PPD WPDs or applicable client SOPs.
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and
current regulatory guidelines as applicable to services provided.
