Job Description
2.0 KEY RESPONSIBILITIES
2.1 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
2.2 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
2.3 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
2.4 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