Practicante Regulatorio de global Clinical Trial
hace 6 meses
Nuestra División de Salud Humana mantiene una ideología que consiste en “primero el paciente, los beneficios más tarde”. La organización está compuesta por ventas, marketing, acceso al mercado, análisis digitales y profesionales comerciales a los que les apasiona su papel de llevar nuestros medicamentos a nuestros clientes de todo el mundo.
Nuestro equipo de asuntos regulatorios trae nuevos avances médicos al mundo facilitando las comunicaciones y los procedimientos que permiten un cumplimiento rápido y organizado con las agencias reguladoras externas. Estamos a la vanguardia de los avances en la atención sanitaria que ayudan a proporcionar productos, prácticas y soluciones médicas nuevas, de cumplimiento y de confianza para el mundo.
Objetivos de la posición:
- Brindar apoyo administrativo en la elaboración y preparación de un expediente presentado a las autoridades regulatorias (ej: solicitud de autorización de ensayos clínicos, enmiendas al protocolo, solicitud de licencia de importación, etc.)
- Monitoreo de los expedientes presentados a las autoridades regulatorias, brindar reportes periódicamente y escalar problemas según aplique
- Realizar la revisión preliminar de documentos estándares (ej: certificado de análisis) usando herramientas de verificación (ej: listas de control)
- Brindar apoyo administrativo en la coordinación, recolección, organización de datos e información y redacción de documentos requeridos por las autoridades locales (ej: comités de ética, INS), los equipos clínicos y casa matriz
- Edición y revisión de consentimientos informados (ej: global, asentimiento, muestras biomédicas futuras, etc.) según regulaciones locales y los procesos internos
- Brindar apoyo en el sometimiento de reportes de seguridad (SUSARs) a los Comites de Ética
- Participar activamente en las iniciativas y/o proyectos de mejora de procesos regulatorios
- Interactuar con otras áreas internas de soporte según necesidad (ej: farmacovigilancia, adquisiciones, finanzas, etc.)
- Manejo de la documentación regulatoria
Requerimientos:
- Estudios universitarios en Farmacia y/o Bioquímica (o similares)
- Nível de inglés intermedio
- No es indispensable tener experiência laboral previa
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Temporary (Fixed Term)
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R277200
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