||Tuesday, April 20, 2021
The Toxicology Consultant works mainly on consulting projects focused primarily on pharmaceutical drug development and secondarily on medical devices. The Toxicology Consultant may serve as Study Director for GLP and non-GLP toxicology studies.
ESSENTIAL DUTIES AND RESPONSIBILITES:
- Develop nonclinical project strategies for Pharmaceutical projects
- Serve as preclinical representative for client project teams
- Review data, protocols, reports and identify/troubleshoot issues
- Conduct literature searches and review
- Integrate data into safety assessments
- Prepare regulatory submission documents and interact with Regulatory agencies
- Potential to serve as Study Director for GLP and non-GLP Toxicology studies
- Prepare biological evaluation reports to support regulatory submissions
- Potential involvement/leadership roles in different committees
- Assess toxicology/biocompatibility programs against relevant standards
- Other duties as assigned by Management
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- PhD in Toxicology; or PhD in biological sciences with 3+ years toxicology experience or master’s degree with 5-10 years toxicology experience
- Expertise and experience required
- Critical thinking and evaluation of toxicology-based data
- Toxicology-based Pharmaceutical drug development experience
- Knowledge of relevant Regulations
- Study Director experience a plus
- Experience with preparing sections of Regulatory documents and interactions with Health authorities a significant advantage
- Proficiency with Microsoft Office (Word, Excel, Outlook)
- Strong verbal and written communication skills. Ability to understand verbal and written instructions, procedures, work instructions and SOP's, as well as the ability to give professional presentations, interact with clients verbally and in writing, and prepare reports which adequately convey information to clients.
- Knowledge of basic statistics.
For more information, or to apply, please contact us at HR@iuvobioscience.com.
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