Turacoz is looking for young, enthusiastic people for its regulatory team. Under regulatory writing, you will be involved in the preparation of various clinical trial and regulatory documents like clinical study protocols, clinical study reports, clinical/non-clinical overviews etc. Based on your position, your role may vary from writing the documents to their review, client dealing, and the whole project management. You will get a chance to get hands-on experience on multiple documents and grow professionally every day.
Who can apply?
Candidate with 1-3 years of experience in regulatory writing can apply for this job position.
The candidate should have hands on experience in:
- Clinical study synopsis and protocols
- Clinical study reports (CSRs)
- Investigator’s brochures (IBs)
- Informed consent form (ICF)
- Case report form (CRF)
- Patient narratives
- Integrated summary of efficacy (ISE)
- Integrated summary of safety (ISS)
- Clinical and non-clinical sections of the common technical document (CTD)
- Clinical trial disclosures
- Risk management plan (RMP)
- Periodic safety update report (PSUR)/Periodic benefit-risk evaluation report (PBRER)
- Development safety update report (DSUR)
- Web synopsis
Required Experience : 1-3 years of experience in regulatory writing
Skills : Strong written and verbal communication, good medical knowledge, data interpretation and presentation, client handling, team player, and most of all, eagerness to learn and accept challenges
Required Qualification : B.Pharma, M.Pharma, BDS, MDS, MBBS or PhD with experience in regulatory writing
Job Location : New Delhi