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Administracja biurowa » Pracownik biurowy

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Opis:

Regulatory Submissions Coordinator / Senior Regulatory Submissions Coo Nr ref.: /JOBS.pl POSITION SUMMARY Their European activities are growing rapidly, and they are currently seeking a full-time, office-based 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. My clients employees embody their values and their 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 my client's team. DUTIES AND MAIN 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 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. QUALIFICATIONS/REQUIREMENTS • Bachelor's degree in life sciences; • Excellent organization and communication skills; • Knowledge of Microsoft® Office; • Hands-on experience preparing, reviewing, and submitting regulatory documentation; • At least one year of work experience as a Regulatory Submissions Coordinator; • Minimum 4 years' experience for the Senior Regulatory Submissions Coordinator position; • Fluency in English and German language. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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