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21.09.2019

Anstellungsart

Vollzeit

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Kontakt

CTI Clinical Trial and Consulting Services Europe GmbH
Schillerstraße 1/15
89077 Ulm

Einsatzort:

Ulm

Bei Rückfragen

Samy Weise
0731/40008435

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93
This position is responsible for providing regulatory administrative support to the Regulatory Specialists in the CTI EU Headquarter in Ulm/Germany. Duties will include entry and tracking of trial related regulatory documentation, assist in studies

Regulatory Project Coordinator (level dependent upon experience)

21.07.2019
CTI Clinical Trial and Consulting Services Europe - Ulm
Pharmazie, Arbeitsmedizin, Gesundheitsmanagement, Dokumentationswesen

Aufgaben

• Assist in compilation and revision of Regulatory Affairs (RA) documents required for clinical trials submissions.
• Assist in the contact with local study teams for RA documents collection and checks, when applicable,
• Assist in preparation of study submission packages (Initial Submissions, Substantial Amendments and Non-substantial Amendments) to Ethics and Competent Authority.
• Arrange for shipments of regulatory documents and packages, track and retrieve items, when needed
• Assist in SUSARs submission package preparation to Central and Local Ethics Committees as well as Competent Authorities in applicable countries
• Assist in the preparation and completion of specific trackers

Qualifikation

• Minimum of 6 months clinical research or research related experience
• Bachelor’s Degree in allied health fields such as nursing, pharmacy or health / natural science
• Excellent English and German Language Skills

Benefits

• We support career progression –25 of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
• We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• Our culture is unparalleled – Click here to learn more about “The CTI Way”
•We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)
• We are looking toward the future – We have had a consistent 15 grow

Weitere Angaben

Sprachkenntnisse: Deutsch - Englisch
Beginn: 15/07/2019
Dauer: unbefristet
Vergütung: nV
Anzahl der Plätze: 1

Angaben zum Unternehmen

Unternehmensbeschreibung


Unternehmensgröße
21-50 Mitarbeiter

Branchen
Herst. von pharmazeutischen Spezialitäten, Sonstige Überlassung von Arbeitskräften, Unterricht a. n. g., Sonstige selbstständige Tätigkeiten im Gesundheitswesen, Unternehmensberatung

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