Medical Writer
hace 1 mes
Resumen del puesto:
El Document Medical Writer será responsable de la recopilación y edición de documentos regulatorios y científicos, con un enfoque especial en procesos de submission y en la anonymization y redaction de datos para cumplir con las regulaciones de protección de datos. Este rol es crucial para asegurar la precisión y la conformidad regulatoria de nuestras comunicaciones científicas.
Requisitios del Perfil:
- Recopilar y revisar documentos científicos y regulatorios, incluyendo pero no limitado a protocolos de estudio, informes de resultados, manuscritos para publicación, y documentos de submission.
- Implementar estrategias de anonymization y redaction para asegurar la confidencialidad y cumplimiento con las normativas de protección de datos en todos los documentos regulatorios.
- Colaborar estrechamente con equipos de asuntos regulatorios, clínicos y farmacovigilancia para desarrollar y mantener documentos de alta calidad.
- Gestionar múltiples proyectos de redacción simultáneamente, asegurando la entrega oportuna y precisa de todos los documentos.
- Permanecer actualizado con las últimas regulaciones y directrices en la industria farmacéutica y ajustar las prácticas de redacción según sea necesario.
- Trabajar con veeva vault, sharepoint y con los TMF.
Requisitos del perfil:
- Grado avanzado en Ciencias de la Salud (por ejemplo, PharmD, PhD, MD).
- Experiencia mínima de 1 año en redacción médica, con un enfoque específico en documentos regulatorios y científicos.
- Experiencia comprobada en la gestión de procesos de submission y en la implementación de técnicas de anonymization y redaction.
- Excelente capacidad de redacción en inglés técnico y científico.
- Fuertes habilidades organizativas y capacidad para trabajar de manera eficiente bajo presión.
- Profundo conocimiento de las normativas ICH, FDA, EMA y otras relevantes a nivel global.
- Competencia en el uso de software de procesamiento de texto y gestión de datos.
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