Experienced Regulatory Submissions (Study Start Up) Coordinator

Medpace; Deutschland; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading clinical research organization in Germany is seeking a Regulatory Submissions Coordinator. You will be part of a dynamic team in Munich, preparing and submitting regulatory documentation, while gaining critical experience in the field. The ideal candidate holds a Bachelor's degree in Life Sciences and is fluent in both German and English. Competitive compensation and a flexible work environment are offered.

Leistungen

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Qualifikationen

• Experience preparing regulatory documentation for Ethics Committees and Regulatory Agencies.
• Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site.
• Knowledge of regulatory guidelines in the DACH region.

Aufgaben

• Prepare and file clinical trial applications to regulatory authorities.
• Submit responses to queries and amendments to clinical trial applications.
• Advise team members on changing regulations.

Kenntnisse

Excellent organizational and prioritization skills

Fluency in German and English

Attention to detail

Proactive work approach

Ausbildung

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Jobbeschreibung

Overview

As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a productive member of the team office-based in Munich, 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

• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland;
• Prepare and submit responses to queries and amendments to clinical trial applications;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise team members on changing regulations and compliance requirements;
• Maintain the Clinical Trial Management System and ensure timely filing of documents;
• Collection of essential documents and preparation essential documents packages for drug release.

Qualifications

• A minimum of a Bachelor\'s degree is required (preferably in a Life Sciences field);
• Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;
• Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
• Knowledge of regulatory guidelines in DACH region;
• Excellent organizational and prioritization skills;
• Use to work independently with a proactive approach;
• Knowledge of Microsoft Office;
• Fluency in German and English;
• Great attention to detail and excellent oral and written communication skills.

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

• 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.