Study Director / Technical Assistant - Non-clinical Toxicity studies

Eurofins

Bengaluru

On-site

INR 1,200,000 - 1,800,000

Full time

38 hours ago
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Job summary

Eurofins Bengaluru seeks a Study Director / Technical Assistant for non-clinical toxicity studies. This full-time role leads study execution, ensures GLP compliance, and coordinates with sponsors and cross-functional teams to deliver high-quality results.

You will oversee planning, data interpretation, and reporting, manage regulatory submissions, and mentor a team to uphold rigorous scientific standards and timelines in a fast-paced environment in India.

Qualifications

  • GLP, OECD, ICH, FDA and EPA guidelines compliance
  • Lead study execution including planning, conduct, oversight, data interpretation and reporting
  • Regulatory submission support and sponsor communications
  • Cross-functional coordination with sponsors, pathology, analytical, QA teams
  • Strong analytical thinking, attention to detail and time management

Responsibilities

  • Serve as Study Director, Principal Investigator, or Technical Assistant for non-clinical toxicity studies
  • Ensure full compliance with GLP and regulatory guidelines
  • Lead all aspects of study execution and reporting
  • Coordinate with sponsors and cross-functional teams
  • Support regulatory submission activities
  • Maintain adherence to study timelines and deliverables
  • Provide regular study progress updates and mentorship

Skills

Leadership
Regulatory knowledge
Data interpretation
Reporting
Time management
Communication

Education

PhD or MSc in toxicology/pharmacology

Job description

Study Director / Technical Assistant - Non-clinical Toxicity studies
  • Full-time

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
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