Regulatory Submissions (Study Start Up) Coordinator (Madrid)

Regulatory Submissions (Study Start Up) Coordinator (Madrid)

04 ago
|
Medpace
|
Madrid

04 ago

Medpace

Madrid

ppOur clinical operations activities are growing rapidly, and we are currently seeking a Regulatory Submissions Coordinator to join our Clinical Operations team in Spain. This position plays a key role in the clinical trial management process at Medpace. bPlease note that this is an office‑based position in Madrid /b. 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. /p h3Responsibilities /h3 ul liPrepare, review, and file initial clinical trial applications to regulatory authorities; /li liPrepare and submit responses to queries and amendments to clinical trial applications; /li liEnsure submissions comply with applicable regulations and guidance documents; /li liAdvise team members on changing regulations and compliance requirements; /li liMaintain the Clinical Trial Management System and ensure timely filing of documents; /li liCollection of essential documents and preparation essential documents packages for drug release. /li /ul h3Qualifications /h3 ul liA minimum of a Bachelor's degree is required (preferably in a Life Sciences field); /li liExperience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; /li liRelevant working experience at a CRO, Pharmaceutical Company, or an investigative site; /li liKnowledge of regulatory guidelines; /li liExcellent organizational and prioritization skills; /li liUse to work independently with a proactive approach; /li liKnowledge of Microsoft Office; /li liFluency in Spanish and English; /li liGreat attention to detail and excellent oral and written communication skills. /li /ul pWe kindly ask to submit applications in English.



/p h3Medpace Overview /h3 pMedpace 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 integral 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. /p h3Why Medpace? /h3 pPeople. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. /p pThe 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. /p h3Medpace Perks /h3 ul liFlexible work environment /li liCompetitive compensation and benefits package /li liCompetitive PTO packages /li liStructured career paths with opportunities for professional growth /li liCompany-sponsored employee appreciation events /li liEmployee health and wellness initiatives /li /ul h3Awards /h3 ul liRecognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 /li liContinually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility /li /ul h3What To Expect Next /h3 pA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. /p /p #J-18808-Ljbffr

📌 Regulatory Submissions (Study Start Up) Coordinator (Madrid)
🏢 Medpace
📍 Madrid

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