Study Start Up - Regulatory Submissions Coordinator
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plaats
Munich
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Sectoren:
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salaris:
benefits package
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Contact:
Denise Saab
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Contact email:
Denise.Saab@volt.eu.com
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functie ref:
74008-PHARM-DEB_1561642123
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gepubliceerd:
bijna 5 jaar geleden
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Vervaldatum:
2019-07-27
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Begin datum:
May
·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.
Clinical Operations role
Qualifications:
·Bachelor's degree in life sciences;
·Excellent organisation 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;
·Fluency in English and German language.