Job Description

Department Details
Role Summary
1] CRU Head:

• BE Study monitoring
• IMP management
• CRO Qualification
• Evaluation of CRO for execution of Clinical studies
• Preparation of Protocol Synopsis
• Review and finalization of study protocol and report
• Preparation of Controlled Correspondence scientific advice, SEC Meeting and Executive Summary for Regulatory submission
• Regulatory query response
• Clinical & Non-Clinical Overview preparation
• Preparation of Clinical Documents Related to Devices
• Preparation of Executive summaries, Controlled correspondence, Scientific advice, executive summaries for Regulatory submissions
• Result evaluation
• Establishing IVIVC models from In-Vitro/In-Vivodata
• BE Prediction of new Test formulation evaluation and selection for batch for subsequent BE study
• To evaluate the critical PK aspects and discuss the same with FnD to improve biostudy success rate
• New product evaluation and Budget estimation
• Supporting dossier submission for extended markets
• Coordination with internal team, CRO and other vendors for timely execution and submission of BE
• Maintenance of Project Tracker for BE Studies
• Departmental Training Coordinator
• Bio study execution at CROs within Budget
• Coordinate with Finance and legal team for CDA, MSA, Project Contracts with Vendors/CROs Over all InCharge of clinical research unit and its related operations.

2] CRU Clinical Operation:

• BE Study monitoring
• IMP management
• CRO Qualification
• Evaluation of CRO for execution of Clinical studies

3] CRU Program Management

• New product evaluation and Budget estimation
• Supporting dossier submission for extended markets
• Coordination with internal team, CRO and other vendors for timely execution and submission of BE
• Maintenance of Project Tracker for BE Studieso Departmental Training Coordinator
• Bio study execution at CROs within Budget
• Coordinate with Finance and legal team for CDA, MSA, Project Contracts with Vendors/CROs

4]CRU Medical Writing / Review:
Preparation of Protocol Synopsis

• Review and finalization of study protocol and report
• Preparation of Controlled Correspondence scientific advice, SEC Meeting and Executive Summary for Regulatory submission
• Regulatory query response
• Clinical & Non-Clinical Overview preparation
• Preparation of Clinical Documents Related to Devices
• Preparation of Executive summaries, Controlled correspondence, Scientific advice, executive summaries for Regulatory submissions

5]CRU Clinical Operation:

• BE Study monitoring
• IMP management
• CRO Qualification
• Evaluation of CRO for execution of Clinical studies

Key Responsibilities
1) Chief Scientific Manager, Biocon Pharma Limited Bangalore.
Key Responsibilities:
? Planning, coordination and execution of biostudies for different Regulatory Markets.
? Contribute as member of Clinical development leadership team to continuous harmonization, process improvement initiatives, Knowledge sharing and setting the excellence framework for Clinical Research.
? Conducting Preclinical PK and toxicity studies.
? Clinical Strategy and Scientific Advice to support development of Generic and Complex Generic Product.
? Support Formulation R &D for Study Design, Bio strategy, Data Interpretation and in -vitro-in-vivo correlation using simulation software.
? Review and provide inputs of Clinical documents: Protocol Synopsis, Study Protocol, ICF, Clinical study Report.
? Study Monitoring and Audit of Clinical Research Organization to ensure quality and Regulatory compliance.
? Provide scientifically rational responses to bio-deficiency received from Drug Regulatory Authorities.
? Portfolio Evaluation, Clinical due diligence, Budgetary requirement
Educational Qualifications
Required Education Qualification: Ph.D
Required Experience: 10 - 20 years

Skills Required