Principal Scientist

5 days ago


india Biocon Pharma Limited Full time

Department Details Role Summary Job Requirement for Clinical Research Role - Assistant Manager- Oversee the clinical Operations and study conduct at CROs- Qualification of CROs or Vendors or sites or Monitors- Preparations of Protocol Synopsis and Review the Protocol, ICF, CRF, other study documents- Conduct Remote/On site Monitoring of Clinical & Bioanalytical phases Key Responsibilities - Oversee the clinical Operations and study conduct at CROs- Qualification of CROs or Vendors or sites or Monitors- Preparations of Protocol Synopsis and Review the Protocol, ICF, CRF, other study documents- Conduct Remote/On site Monitoring of Clinical & Bioanalytical phases- Review the CSR- Handling regulatory Queries and submission of regulatory query responses to RS team- Evaluation/assessment of study feasibility, budget preparation.- Evaluation of In-licensing dossiers- Preparation and Review of Controlled Correspondence scientific advice for Regulatory-submission- Clinical Overview preparation & Review- Supporting Regulatory team in submission of ANDAs to extended markets. Educational Qualifications Required Education Qualification: M.PharmaRequired Experience: years



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