LATAM Study Start-Up Submissions Lead

Medpace, Inc.; Buenos Aires; On-site; ARS 1,200,000 - 2,000,000; Full time

Job summary

Medpace, Inc. in Buenos Aires is seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in LATAM. The role focuses on managing global start-up activities, regulatory submissions, and ensuring quality of essential documents.

The ideal candidate has at least 4 years of regulatory submissions/start-up management experience, LATAM regulatory knowledge, strong communication, and leadership skills. Fluency in English and local language is required.

Qualifications

• At least 4 years of regulatory submissions/start-up management experience (leading regulatory/start-up project teams).
• Knowledge and experience of Clinical Trial Applications within Latam.
• Strong oral and written communication skills.
• Team oriented approach and strong leadership skills.
• Willing to work in an office-based model; and
• Fluency in English & local language

Responsibilities

• Efficiently manage and successfully 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 and challenges; and
• Present during bid defenses, general capabilities meetings, and audits.

Skills

Regulatory submissions

Study start-up

LATAM regulations

Leadership

English fluency

Job description

Medpace, Inc. in Buenos Aires is seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in LATAM. The role focuses on managing global start-up activities, regulatory submissions, and ensuring quality of essential documents.

The ideal candidate has at least 4 years of regulatory submissions/start-up management experience, LATAM regulatory knowledge, strong communication, and leadership skills. Fluency in English and local language is required.