Medical Writer

hace 1 mes


Barcelona, Barcelona, España Morgan Philips Executive Search A tiempo completo

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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