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Urgent! Practicante Regulatorio de Global Clinical Trial Operations Job Opening In Lima – Now Hiring MSD LATAM

Practicante Regulatorio de Global Clinical Trial Operations



Job description

Job Description
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 del practicante de regulatorio para GCTO

  • Proporcionar entrenamiento en el área regulatoria dentro del marco de un estudio clínico
  • Proporcionar conocimientos en Buenas Prácticas Clínicas, Regulaciones Locales e Internacionales que rigen la ejecución de estudios clínicos
  • Proporcionar experiencia en la interacción con agencias regulatorias

Tareas

  • 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
  • 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.)
  • Brindar apoyo en el sometimiento de reportes de seguridad (SUSARs) a los Comites de Ética
  • Manejo de la documentación regulatoria

Requerimientos

  • Estudiantes de los ciclo de 7mo en Farmacia y/o Bioquímica
  • Nivel de inglés intermedio
  • Ideal conocimientos en Power BI (no excluyente)

Required Skills
Analytical Problem Solving, Analytical Problem Solving, Clinical Operations, Clinical Research, Clinical Testing, Clinical Trial Compliance, Clinical Trials Analysis, Communication, Communication Coordination, Communication Management, Data Analytics, Database Management, Data Entry, Data Visualization, Document Management, Good Clinical Practice (GCP), Health Economics, Management Process, Marketing Management, Office Applications, Process Improvement Projects, Process Improvements, Project Management, Regulatory Submissions, Reporting and Analysis {+ 3 more}

Preferred Skills
Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

Where agency agreements are in place, introductions are position specific.

Please, no phone calls or emails.

Employee Status
Intern/Co-op (Fixed Term)

Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid

Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
10/17/2025

  • A job posting is effective until PM on the day BEFORE the listed job posting end date.

    Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R


Required Skill Profession

Other General



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