Study Start Up Manager

Medpace, Inc.; São Paulo; Presencial; BRL 180 000 - 300 000; Tempo integral

Resumo da oferta

Medpace, Inc. in Sao Paulo, Brazil, is seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team. You will lead regulatory submissions and start-up activities for LATAM markets, ensuring quality documents and regulatory compliance.

Ideal candidates have 4+ years in regulatory submissions, LATAM experience, strong communication, and leadership, with fluency in English and Portuguese, and willingness to work in an office-based role in Brazil.

Qualificações

• 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.
• 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.

Conhecimentos

Regulatory submissions

Start-up management

LATAM CTAs knowledge

Communication skills

Team leadership

Office-based work

English & Portuguese

Descrição da oferta de emprego

Job Summary

Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo! This position plays a key role in the study start up process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

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.

Qualifications

• At least 4 years ofregulatory 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

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.