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Toxicologist

Company: Next Science
Location: Jacksonville
Posted on: September 15, 2019

Job Description:

Toxicologist: This position will report to the Clinical Research Director of Next Science in the Research and Development group. This position represents R&D on cross-functional product development teams. The person in this role is responsible for independently designing, contracting and reporting in-vitro and in-vivo toxicology programs and integrating these data into human and animal health risk assessments to support new product development and regulatory filings. As a member of project teams, the toxicologist is responsible for cross-functional collaboration for project team deliverables, including leading sub-teams and task forces when required. The toxicologist will support in-line projects and independently prepare technical reviews and position papers to address drug, device, residue and other safety issues. Experience: · B.S. in toxicology and/or pharmacology; M.S. or Ph.D. preferred · 2 years of relevant industry experience · Knowledge of bench, applied and regulatory toxicology · Understanding of pharmaceutical and device development and human health risk assessments. · Accomplished at technical writing · Knowledge of Good Laboratory Practices (GLP); GLP Study Director experience is a plus. · Possess the skills to successfully negotiate regulatory outcomes employing novel technical arguments Responsibilities: Functions as in-house consultant and subject matter expert in areas of expertise Keeps current with worldwide regulations for assessing safety of veterinary compounds. Participates in presentations to regulatory agencies, when needed. Active participant in professional/technical associations. Functions as a Sponsor Representative on toxicology, safety, PK, exposure studies, as well as analytical supporting studies. Develops protocols and designs studies in collaboration with CROs. Conducts or directs all activities in compliance with established regulatory requirements. Evaluates, interprets, reviews and summarizes technical data. Prepares and reviews reports, memos, SOPs and regulatory documents with minimal oversight. Responsible for preparation of User Risk Assessments. Leads or participates effectively in teams and is able to shift priorities and projects as needed to align with functional, R&D and/or regulatory priorities. Excellent communication skills of writing and speaking to be effective on the job. Extensive experience defining toxicity and safety testing requirements and implementing programs. Working knowledge of international regulatory guidelines applicable to toxicity, safety and exposure studies, risk assessments and data interpretation by regulatory bodies. Act at all times according to industry and Company standards and ethics. Assure appropriate reporting of data to support complex regulatory submissions. As necessary, provide support for presentation and discussion of safety positions to regulators.

Keywords: Next Science, Jacksonville , Toxicologist, Other , Jacksonville, Florida

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