Regulatory Start-Up Lead, LATAM Trials

Medpace; Buenos Aires; Presencial; ARS 1.000.000 - 1.400.000; Jornada completa

Descripción de la vacante

Medpace LATAM is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team in Buenos Aires. This office-based role plays a key part in the study start up process, leveraging your regulatory and project leadership experience to deliver timely submissions.

You will work with cross-functional teams, perform quality checks on documents, review regulations, and present at audits and bid defenses.

Formación

• Submit CV in English
• At least 4 years of regulatory submissions/start-up management experience
• 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
• Fluency in English & local language

Responsabilidades

• 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
• Present during bid defenses, general capabilities meetings, and audits

Conocimientos

Regulatory submissions

Start-up management

Clinical Trial Applications LATAM

Fluent English

Fluent in local language

Strong communication skills

Team leadership

Descripción del empleo

Medpace LATAM is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team in Buenos Aires. This office-based role plays a key part in the study start up process, leveraging your regulatory and project leadership experience to deliver timely submissions.

You will work with cross-functional teams, perform quality checks on documents, review regulations, and present at audits and bid defenses.