Regulatory Submissions Coordinator
hace 1 día
Medpace, a leading full-service clinical contract research organization, is seeking a highly skilled Regulatory Submissions Coordinator to join its Clinical Operations team in Madrid. This exciting opportunity plays a key role in the clinical trial management process, ensuring timely and compliant submissions to regulatory authorities and Ethics committees.
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 of essential documents packages for drug release.
- Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.
- 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.
None
Medpace Overview:Medpace is a full-service clinical contract research organization (CRO) providing 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 our 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 over 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.
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