Country Approval Specialist
hace 4 semanas
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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Country Approval Specialist
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Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
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Sr Country Approval Sp
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Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo[16:21] Michelle Christophersen 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)...
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Country HR Consultant
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Sso Finance Specialist
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Site Activation Specialist
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FSP Sr. Site Activation Specialist in Argentina
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Buenos Aires, Argentina IQVIA A tiempo completoJob Overview The Regulatory & Start Up Specialist 2 will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. ...
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Regulatory Affairs Specialist
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Digital Quality Control Specialist
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Senior Site Activation Specialist
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Inside Sales/lead Generation Specialist
hace 7 días
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Specialist, Marketing
hace 1 mes
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Affiliate marketing
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Workplace Experience Specialist
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Trade and Transportation Specialist
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Environment, Health and Safety
hace 4 semanas
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Coordinator of The Zfd-program
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