Experienced Regulatory Submissions Coordinator, Study Start Up & Maintenance

Clinical Operations        ·        Poland-Warsaw | Poland-Warsaw      ·       Full time

Job Summary

Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based, with the option to work from home partially, Regulatory Submissions Coordinator to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. 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.

Ours is a culture of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our partners. At Medpace our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons talented individuals join the Medpace team.

Responsibilities

• Prepare, review, and file clinical trial applications to country agencies and ethic committees;
• Provide insightful input on regulatory submissions documents and timelines;
• 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

• A minimum of Bachelor’s degree in life sciences;
• Excellent organization and communication skills, great attention to detail;
• Hands-on experience preparing, reviewing, and submitting regulatory documentation;
• At least two-three years of work experience as a Regulatory Submissions Coordinator or equivalent;
• Comprehensive knowledge of ICH/GCP guidelines and local regulations;
• Knowledge of Microsoft® Office; and
• Fluency in English and Polish language

Travel: Minimal

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?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter’s campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.

Perks (vary by location and position):

• On-site fitness center(s)
• Campus walking paths
• Company-sponsored social and wellness events
• Official Sponsor of FC Cincinnati
• Hybrid work-from-home options and flexible work schedule
• On-site Market Place
• Free and covered parking
• Discounts for local businesses
• On campus restaurants and banks coming soon

Awards:

• Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America’s Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

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