LATAM Study Start-Up Regulatory Lead

Medpace; Ciudad de México; Presencial; MXN 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

Medpace in Mexico City is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team. You will lead global start-up activities, ensure quality of regulatory submission documents, and prepare informed consent forms, driving regulatory compliance and successful studies.

The role requires 4+ years in regulatory submissions/start-up management, leadership abilities, and fluency in English and the local language.

Formación

• Bachelor's degree in life sciences is required.
• 4+ years of regulatory submissions/start-up management experience.
• Strong leadership and team-oriented skills.
• Fluency in English and local language.

Responsabilidades

• Efficiently manage and execute all aspects of global start-up.
• Perform quality checks on submission documents and site essential documents.
• Prepare and approve informed consent forms.
• Review pertinent regulations to develop proactive solutions to start-up issues.
• Present during bid defenses, general capabilities meetings, and audits.

Conocimientos

Regulatory submissions

Start-up management

Leadership

Communication

English fluency

Educación

Bachelor's degree in life sciences

Descripción del empleo

Medpace in Mexico City is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team. You will lead global start-up activities, ensure quality of regulatory submission documents, and prepare informed consent forms, driving regulatory compliance and successful studies.

The role requires 4+ years in regulatory submissions/start-up management, leadership abilities, and fluency in English and the local language.