Experienced Study Start Up Specialist

Medpace; São Paulo; Presencial; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

Join a dynamic team as a Regulatory Submissions Coordinator, where you will support crucial projects in clinical research. This role offers a unique opportunity to gain hands-on experience and develop your skills in a full-service clinical contract research organization. You will be mentored by experienced professionals while contributing to the submission of vital regulatory documents. With a focus on compliance and quality control, your efforts will directly impact the development of safe and effective medical therapies. This is your chance to make a difference in the lives of patients and families across the globe.

Serviços

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Qualificações

• Bachelor's degree required, preferably in Life Sciences.
• 3-4 years of regulatory submissions experience needed.

Responsabilidades

• Support regulatory submissions and ensure compliance with regulations.
• Conduct quality control of documents and provide guidance.

Conhecimentos

Organizational Skills

Prioritization Skills

Attention to Detail

Oral Communication

Written Communication

Fluency in English

Formação académica

Bachelor's Degree in Life Sciences

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Job Summary

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

1. 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;
2. Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
3. Conduct quality control of documents;
4. Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
5. Perform other tasks as needed.

Qualifications

1. Bachelor's degree is required (preferably in a Life Sciences field) and at least 3 - 4 years of regulatory submissions experience;
2. Excellent organizational and prioritization skills;
3. Knowledge of Microsoft Office;
4. Great attention to detail and excellent oral and written communication skills;
5. Fluency in spoken and written English.

We kindly ask to submit applications in English.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

1. Flexible work environment
2. Competitive compensation and benefits package
3. Competitive PTO packages
4. Structured career paths with opportunities for professional growth
5. Company-sponsored employee appreciation events
6. Employee health and wellness initiatives

Awards

1. Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
2. Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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