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Regulatory Submissions Coordinator/Senior Regulatory Submissions Coord - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresGermany,
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Regulatory Submissions Coordinator/Senior Regulatory Submissions Coord

Nr ref.: /JOBS.pl

  • Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team!

    Our clinical activities are growing rapidly, and we 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.

    • 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.

    • 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.

    At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.

    We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.

    EO/AA Employer M/F/Disability/Vets


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