Bioequivalence Specialist İş İlanı
İşveren Hakkında
- İstanbul(Avr.)(Bağcılar)
- İlaç Sanayi
GENEL NİTELİKLER
- Min Bachelor od Science degree in life sciences preferably in Pharmacy, Veterinary, Chemistry or Biology or Molecular Biology and Genetics or Medical Doctor,
- 1-2 years of similar experience in the pharmaceutical industry or CRO in Clinical Research environment,
- Solid working understanding of the clinical research, GCP, local and global regulations, and guidelines,
- Preferably, Experience in Co-ordinating with Sponsor and CROs/Investigator sites for study monitoring activities and updates,
- The GCP training and certification,
- Excellent knowledge of English,
- Excellent knowledge of Microsaoft Office Applications,
- No military obligation for male candidates.
JOB DESCRITION
- Planning of bioequivalence studies,
- Review and approval of all study related documention including protocols and Final Study Report,
- Determining the clinical requirements of products developed in R&D department,
- Literature search for preparation biowaiver reports when biowaiver is applicable,
- Study Medication Handling, Management, Distribution and Drug accountability,
- Providing necessary support to Regulatory department related clinical/BE study requests during registration.
