Site Activation Coordinator

Medpace, Inc.; São Paulo; Presencial; BRL 90 000 - 130 000; Tempo integral

Resumo da oferta

Medpace, Inc. in Brazil is seeking a Regulatory Submissions Coordinator to join our growing Regulatory Submissions team.

You will support study start up and gain hands-on experience while working closely with Submissions Coordinators to ensure regulatory timelines are met. The ideal candidate has a Life Science background and English proficiency, with 1–4 years of regulatory submissions experience and familiarity with ANVISA (RA) submissions; CTNBio is a plus.

Qualificações

• Bachelor's degree in Life Sciences; 1–4 years regulatory submissions experience preferred.
• Experience with ANVISA (RA) submissions required.
• Experience with biosafety/CTNBio submissions desirable.
• Interest or experience with regulatory surveillance and strategy.
• Excellent organizational and prioritization skills.
• Fluent in English, both written and spoken.

Responsabilidades

• Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
• Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
• Conduct quality control of documents;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
• Perform other tasks as needed.

Conhecimentos

English proficiency

Organizational skills

Attention to detail

Communication skills

Regulatory submissions

Formação académica

Bachelor's degree in Life Sciences

Master's/PhD preferred

Ferramentas

Microsoft Office

ANVISA (RA) submissions

Descrição da oferta de emprego

Job Summary

Our team in Brasil is growing! As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining vital experience in study start up. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you will gain valuable hands on experience to enable you to develop a career in clinical research.

Responsibilities

• Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
• Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
• Conduct quality control of documents;
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
• Perform other tasks as needed.

Qualifications

• Life Science Bachelor's degree is required, advanced degree preferred (master's/PhD) 1-4 years of regulatory submissions experience preferred;
• Experience with ANVISA (RA) submissions is required;
• Experience with biosafety commission (CTNBio) submissions is desirable;
• Interest or experience with regulatory surveillance and strategy;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office;
• Great attention to detail and excellent oral and written communication skills; and
• Fluency in spoken and written English.

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.