Regulatory Submissions Coordinator

Medpace; München; Vor Ort; EUR 40.000 - 50.000; Vollzeit

Zusammenfassung

A clinical research organization is seeking an entry-level Regulatory Submissions Coordinator for their office in Munich. The role involves preparing and filing clinical trial applications with a focus on compliance and communication with research sites. Candidates should have a Bachelor's degree in a Life Sciences field and be proficient in both German and English. Flexible work environment and structured career paths are among the perks offered.

Leistungen

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths with opportunities for professional growth

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Qualifikationen

• Interest in drug development and clinical trials.
• Excellent communication skills in both German and English.

Aufgaben

• Prepare, review, and file clinical trial applications for Germany, Austria and Switzerland.
• Communicate with research sites to collect essential documents.
• Ensure submissions comply with applicable regulations.

Kenntnisse

Full professional proficiency in German

Full professional proficiency in English

Knowledge of Microsoft Office

Excellent organization skills

Great attention to detail

Ausbildung

Bachelor's degree (preferably in a Life Sciences field)

Jobbeschreibung

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time office-based Regulatory Submissions Coordinator to join our Clinical Operations team in Munich. This position plays a key role in the clinical trial management 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.

Entry-level positions with permanent contract are available for recent graduates.

Responsibilities

• Prepare, review, and file clinical trial applications for Germany, Austria and Switzerland (DACH);
• Communicate with research sites in Germany, Austria and Switzerland (hospitals, etc.) to collect all essential documents required before the site starts to enroll patients to participate in the clinical trial;
• Provide insightful input on regulatory submissions documents and maintain timelines for study start-up through both internal and external collaboration;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise on changing country regulations and compliance requirements; and
• Track submissions and ensure timely filing of documents.

Qualifications

• Bachelor's degree (preferably in a Life Sciences field);
• Interest in drug development and clinical trials;
• Full professional proficiency in German and English in written and verbal communication;
• Knowledge of Microsoft Office; and
• Excellent organization and communication skills,great attention to detail.

Travel: None

We kindly ask to submit applications in English. We would appreciate if you could indicate the status of your work permit if needed.

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

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• 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.