Julia Kruschel
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Julia Kruschel
- Current 13 years and 2 months, since Apr 2013
Co-Founder, CMO, content Manager
Eduoomph Education Inc.
- 7 months, Jan 2015 - Jul 2015
EU-QPPV
co.don AG
- 2 years, Aug 2013 - Jul 2015
Head of Clinical Research and Head of Regulatory Affairs
co.don AG
Planning and implementation of Clinical Trials Phase II and III; Negotiations with European and national Authorities (Germany, Switzerland) in Scientific Advices, Presentations, Innovation Task Force Meetings, Pre-Submissions, overall Project Management of centralized Marketing Authorization Procedures Management of Non-interventional and retrospective studies Submissions of clinical trials (competent authorities, review boards) GCP training Support of EU-QPPV in set-up of PV system
- 1 year, Feb 2013 - Jan 2014
Self-employed Freelancer
JK Cell Therapy Consulting
Service from Clinical Research to Marketing Authorization - Regulatory Affairs Specialist and Clinical Research Specialist for ATMPs/Cell Therapies Conduct of and independent consulting for all or any operational aspects of a clinical trial and the centralized Marketing Authorization Procedures (EU), as well as national German permission acc. AMG for Advanced Therapy Medicinal Products.
- 8 months, Jan 2013 - Aug 2013
Scientific Sabbatical; Vancouver, Canada
Various Projects
- 3 years and 4 months, Nov 2009 - Feb 2013
Head of Clinical Research and Regulatory Affairs
co.don AG
Planning and implementation of Clinical Trials Phase II and III; Negotiations with European and national Authorities (Germany, Switzerland) in Scientific Advices, Presentations, Innovation Task Force Meetings, Pre-Submissions, overall Project Management of centralized Marketing Authorization Procedures Management of Non-interventional and retrospective studies Submissions of clinical trials (competent authorities, review boards) GCP training Support of EU-QPPV in set-up of PV system
- 6 months, Jun 2009 - Nov 2009
Manager Regulatory Affairs and Clinical Research
co.don AG
- 7 months, Dec 2008 - Jun 2009
Pharmazeutin
Primus Apotheke
Work in public pharmacy, support of other pharmacists, Prescriptions, pharmaceutical drug formulation, customer service
- 2 years and 4 months, Feb 2006 - May 2008
Studentische Hilfskraft
Bibliothek des Botanischen Gartens Berlin
Management of duplicates, Cataloging of botanical library collection, Technical preparation of literature, Collaboration in inter-library loan, Solve and answer customer request
Ausbildung von Julia Kruschel
- 1 month, Nov 2014 - Nov 2014
Drug Safety Manager
Forum Institut
- 5 years and 5 months, Apr 2003 - Aug 2008
Pharmazie
Freie Universität Berlin
Sprachen
German
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
French
A1-A2 (Grundkenntnisse)
Swedish
A1-A2 (Grundkenntnisse)
Turkish
A1-A2 (Grundkenntnisse)
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