Country Approval Specialist

hace 3 días


Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

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.



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