Julia Kruschel
Angestellt, Associate Director Regulatory Affairs, MorphoSys AG
München, Deutschland
Werdegang
Berufserfahrung von Julia Kruschel
Bis heute 11 Jahre und 2 Monate, seit Apr. 2013
Co-Founder, CMO, content Manager
Eduoomph Education Inc.
7 Monate, Jan. 2015 - Juli 2015
EU-QPPV
co.don AG
2 Jahre, Aug. 2013 - Juli 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 Jahr, 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 Monate, Jan. 2013 - Aug. 2013
Scientific Sabbatical; Vancouver, Canada
Various Projects
3 Jahre und 4 Monate, 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 Monate, Juni 2009 - Nov. 2009
Manager Regulatory Affairs and Clinical Research
co.don AG
7 Monate, Dez. 2008 - Juni 2009
Pharmazeutin
Primus Apotheke
Work in public pharmacy, support of other pharmacists, Prescriptions, pharmaceutical drug formulation, customer service
2 Jahre und 4 Monate, Feb. 2006 - Mai 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 Monat, Nov. 2014 - Nov. 2014
Drug Safety Manager
Forum Institut
5 Jahre und 5 Monate, Apr. 2003 - Aug. 2008
Pharmazie
Freie Universität Berlin
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen
Schwedisch
Grundlagen
Türkisch
Grundlagen