Description
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