About this role
- ✓0 KEY RESPONSIBILITIES
- ✓1 Study Leadership and Regulatory Compliance
- ✓Serve as Study Director, Principal Investigator, or Technical Assistant for non-clinical toxicity studies
- ✓Ensure full compliance with GLP, OECD, ICH, FDA, and EPA guidelines, as well as sponsor-specific requirements
- ✓Lead all aspects of study execution, including planning, conduct, oversight, data interpretation, and comprehensive reporting
- ✓Demonstrate expertise in GLP-compliant non-clinical toxicity study design and execution
- ✓Administer test items via multiple routes of exposure with proficiency and precision
- ✓2 Data Management and Scientific Reporting
- ✓Conduct thorough review of study data to identify deviations and inconsistencies
- ✓Evaluate study results objectively and prepare high-quality study reports, amendments, and responses to sponsor inquiries
- ✓Ensure timely and accurate submission of all scientific documentation
- ✓3 Cross-Functional Coordination and Stakeholder Management
- ✓Coordinate effectively with sponsors, pathology, analytical, bioanalytical, veterinary, and quality assurance teams
- ✓Maintain adherence to study timelines and deliverables
- ✓Participate in sponsor meetings and provide regular study updates
- ✓Support regulatory submission activities
- ✓4 Core Competencies
- ✓Scientific and analytical thinking with strong problem-solving capabilities
- ✓Meticulous attention to detail with commitment to quality excellence
- ✓Sound decision-making and critical thinking skills
- ✓Clear and professional communication with sponsors and cross-functional teams
- ✓Leadership capability with mentoring potential
- ✓Full accountability and ownership of study deliverables
- ✓Excellent time management and ability to meet strict deadlines
- ✓Strong knowledge of regulatory frameworks and compliance requirements