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clinical drug development in collaboration with pharmacometrics and statistics groups (as relevant). Provides recommendations for clinical doses and dosing regimens (including drug-drug interactions, food
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, food effects, special group dosing) to the clinical and Development teams and in regulatory documentation. Leads clinical pharmacology contributions to all regulatory documents including Investigator
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administation, blood collection) to research investigators Observe and report status of animal health, food and water consumption, appearance, behavior, etc. Support general operations Required to work with all
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skills Sound interpersonal, decision making and problem solving skills Nice-to-Have Previous Biopharma experience Knowledge of Food and Drug Administration PSM, Good Manufacturing Practices {also cGMP
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knowledge and familiarity of standard construction contracts and documents. Knowledge of Food and Drug Administration PSM, Good Manufacturing Practices {also cGMP} policies and procedures. PHYSICAL/MENTAL
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verbal and written communication skills Sound interpersonal, decision making and problem solving skills Nice-to-Have Previous Biopharma experience Knowledge of Food and Drug Administration PSM, Good
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especially International Conference on Harmonization (ICH), Food and Drug Administration (FDA) and European Medicines Agency (EMA) relevant to clinical and safety data and clinical development and labelling
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experience preferred Regulatory knowledge: Familiarity with global regulatory guidance especially International Conference on Harmonization (ICH), Food and Drug Administration (FDA) and European Medicines
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Experience with in vivo food intake/ body weight studies; or measurements of physical function (max force, treadmill running). Knowledge of metabolism and pharmacology. Experience working in or collaborating