▷ 3 Days Left Principal Scientist

3 weeks ago


India Biocon 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 Pharma Required Experience 5 - 10 years


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