Scientific Writer CMC (m/f)

Baden-Württemberg  ‐ Vor Ort
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Beschreibung


We are looking for a
Scientific Writer CMC (m/f)

Reference: -en
Start: asap
Duration: 12 MM
Place: in Baden-Württemberg
Branch: Pharmazeutische Industrie

Your tasks:
  • Provision of high quality analytical submission documentation for INDs/IMPDs and CTAAs, MAAs
  • Ensure timely and efficient submissions and achieve 'state of the art' performance levels
  • Implementing the critical, long-term scientific and technical analytical concepts and standards for analytical submission documentation for CTAAs, MAAs
  • Evolving regulatory trends


Your qualifications
  • Profound experience in writing CMC documents for IND/IMPD/BLA/MAA, especially for biologics
  • Profound work experience in the pharmaceutical, preferable biopharmaceutical industry
  • Profound Experience and profound knowledge in application and interpretation of pharmaceutical guidelines
  • Preferably biological background
  • Fluent German and English skills



Skills:
- Medical writer
- Regulatory affairs assistant


Keywords: Medical Writer
Start
ab sofort
Dauer
12 MM
Von
Hays AG
Eingestellt
03.07.2015
Ansprechpartner:
Kerstin Werner
Projekt-ID:
937014
Vertragsart
Freiberuflich
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