YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Research Toxicologist, are to: 

• Perform/monitor studies for characterization of acute and repeated-dose (28-day and 90-day) toxicity studies of proteins and nucleic acids (e.g. dsRNAs) for S&T dossier submissions;
• Perform risk assessment by providing input on hazard identification, dose-response interpretation, use of mechanistic data and integrating information from other disciplines;
• Draft white papers, waiver requests, regulatory responses, peer reviewed journal articles, and internal and external communications to support product submissions/approvals;
• Assess critical toxicological findings and propose solution strategies;
• Use strategies and work programs to respond successfully to concerns raised from Regulatory Authorities and other decision makers;
• Provide mechanistic understanding and regulatory support of safety related topics during research and development;
• Summarize and evaluate available data for regulatory submissions & registrations, documentation, reports and dossiers;
• Ensure that customers’ demands on studies and risk assessments are fulfilled with the highest quality while maintaining cost efficiency, on time delivery and proper prioritization.
   

 WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Ph.D. with minimum of three years relevant experience OR M.S. with minimum five years relevant experience OR B.S. with minimum of seven years relevant experience in toxicology, pharmacology, natural sciences or related discipline;
• Comprehensive knowledge and experience in toxicology, regulatory toxicology requirements and processes;
• Experience in conducting human risk assessments regarding new compounds and marketed products, and strong working knowledge and understanding of GLP regulatory requirements;
• Strategic, innovative, with demonstrated competencies in problem solving and analytical thinking;
• Process-oriented thinking and ability to analyze complex data;
• Excellent oral and written communication (including presentation) skills, to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties.

#LI-US