ID EXISTS
POS 3175
Status 10
DJM 1

Regulatory Affairs Data Management

Beschreibung: For one of our German Pharma clients we are looking for freelance support as: Regulatory Affairs Data Management (M/F/*)
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Tasks:
  • Link between the Regulatroy specialist department and IT
  • Data entry
  • Business Admin tasks such as Master Data Management or "Resetting records" IT systems: Trackwise, Registration Tracking Tool and D2 Life Science Suite from OpenText
  • Carry out functional trainings and are the first contact to function or process questions
  • Create queries/analyses and reports on request
  • Monitoring data quality in RIMS through queries and tracking
  • Reporting data to the EMA in accordance with Art. 57
  • Support with data within the framework of serialization
  • Management of the product cycle (in close cooperation with the locations Switzerland, USA and Australia)
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Qualifications:
  • Experience in Regulatory Affairs for Data Entry & TrackWise
  • Ideally first professional experience in QMS TrackWise
  • Technical experience with IT systems in the area of Regulatory Affairs (TIMS and EDMS)
  • Good knowledge of processes and systems with regard to document management
  • Business fluent in English (German is a plus!)
Bemerkungen: WANTED: Regulatory Affairs Data Entry TrackWise Expert (M/F/*). Please contact: +49 89 18 90 998 11 or stefanie.bauer@k-recruiting.com Skills: English, Pharma, Regulatory Affairs
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Interesse geweckt?
Auf geht's!
Beginn: 01.11.2019
Laufzeit: 3 Months
Einsatzort: Hessen
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