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COUNTRY APPROVAL ASSOCIATE
Descripción de la oferta de empleo
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Responsible for the preparation and reviewing with research centers for local EC submissions and supporting the preparation of MoH (ISP) submissions, as appropriate, according to the submission strategy.
As applicable, coordinate with others internal functional departments to ensure activities aligned with the submission and site activation strategy and according to the agreed timelines.
Responsible for preparing and reviewing country and site-specific informed consent forms documents.
Also have contact with the investigators and the study coordinators for activities related to submissions and acted as a key contact at country level for Ethical or Regulatory submission related activities.
Prepare Regulatory Compliance Review packages, including working with the CRA as applicable.
As applicable, coordinate with others internal functional departments to ensure activities aligned with the submission and site activation strategy and according to the agreed timelines.
Responsible for preparing and reviewing country and site-specific informed consent forms documents.
Also have contact with the investigators and the study coordinators for activities related to submissions and acted as a key contact at country level for Ethical or Regulatory submission related activities.
Prepare Regulatory Compliance Review packages, including working with the CRA as applicable.
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Detalles de la oferta
Empresa
- Sin especificar
Localidad
- En todo Chile
Dirección
- Sin especificar - Sin especificar
Tipo de Contrato
- Sin especificar
Fecha de publicación
- 20/01/2025
Fecha de expiración
- 20/04/2025