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 Madrid. 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 are available for recent graduates.
Responsibilities
Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees;
Ensure submissions comply with applicable regulations and guidance documents;
Advise sponsors on changing regulations and compliance requirements;
Track submissions and ensure timely filing of documents;
Collection of essential documents and preparation essential documents packages for drug release;
Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.
Qualifications
A minimum of a Bachelor's degree in Life Sciences is required;
One year of work experience as a Regulatory Submissions Coordinator and/or experience in study start-up tasks is desirable;
Hands-on experience preparing, reviewing, and submitting regulatory documentation is beneficial;
Excellent organizational and prioritization skills, great attention to detail;
Knowledge of Microsoft Office;
Fluency in English.
Travel: None
Note: Only CVs in English will be considered.
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
Hybrid work-from-home options (dependent upon position and level)
Competitive PTO packages
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Flexible work schedule
Competitive compensation and benefits package
Structured career paths with opportunities for professional growth
Awards
Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
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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