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Medical Operations Lead

hace 3 meses

Bogotá, Bogotá D.E., Colombia Takeda Pharmaceutical A tiempo completo

Propósito del puesto:
El Líder de Operaciones Médicas es responsable de garantizar la excelencia operativa y la mejora continua de los procesos de Asuntos Médicos, garantizar la implementación adecuada del sistema de gestión de calidad GxP, la implementación de iniciativas de excelencia médica y apoyar la implementación local de las iniciativas de EG&P

Como va a contribuir:

  • Asegurar el conocimiento de los procesos y plataformas requeridas para la correcta implementación del equipo de Asuntos Médicos.
  • Asegurarse de que todas las políticas y SOP necesarios localmente relacionados con el alcance médico de GxP estén implementados, adaptados y actualizados de acuerdo con los documentos globales correspondientes y las regulaciones locales.
  • Seguimiento de la ejecución estratégica del presupuesto de acuerdo al plan médico.
  • Asegurar la inscripción adecuada y la capacitación de seguimiento en las políticas de GxP.
  • Asociarse con los equipos médicos de los países en la preparación de auditorías e inspecciones, y en el seguimiento adecuado de las acciones y la implementación de los CAPA.
  • Proporcionar supervisión de calidad en las actividades de Asuntos Médicos para garantizar el cumplimiento de los requisitos de las Autoridades Sanitarias y los estándares de Takeda.
  • Ayudar al equipo médico que supervisa las actividades médicas, garantizando:
  • Momento de los acontecimientos.
  • Proceso adecuado para la creación de ponentes y proveedores de servicios de salud.
  • Revisión de los detalles de la contratación alineados con los procedimientos locales y globales de la empresa.
  • Documentación de eventos médicos y seguimiento que detalla alineado con las políticas de GxP

Conocimientos, Experiência:

  • Escolaridad: MD, otro profesional en Ciencias de la Vida titulado o ingeniero/administrador con experiência previa en procesos GXP dentro del Sector Farmacéutico.
  • Experiência demostrada en el entorno de Asuntos Médicos (por ejemplo, PV, Gestión Médica, MSL o Información Médica)
  • Experiência práctica en:
  • Desarrollo e implementación de procesos
  • Detección de problemas de calidad y desarrollo de CAPA
  • Preparación para la inspección y la preparación de la auditoría
  • Garantiza que las actividades de Asuntos Médicos dentro del COL cumplan con los requisitos de las Autoridades Sanitarias y las normas internas, y que esto esté debidamente documentado
  • Garantizar la implementación oportuna de las actividades médicas
  • Takeda se enorgullece de su compromiso por crear una fuerza laboral diversa y brindar igualdad de oportunidades laborales a todas las personas que forman parte de la compañía y a aplicantes, valorando la diversidad, sin hacer distinción por identidad étnicoracial, color, religión, orientación sexual, identidad de género, expresión de género, estado parental, nacionalidad, edad, discapacidad, características genéticas, estado civil u alguna otra característica. Nuestras oportunidades laborales siguen este compromiso de promover una cultura incluyente y equitativa._

Locations:

Bogota, Colombia

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time