About this role
Job Description Summary -Directs and manages toxicological and/or pathological studies data in preclinical safety and efficacy testing on new and marketed products. Establishes policies for use of contract laboratories and consultants. Support audit and HAQ from FDA and other regulatory agencies.
Support in conducts and summarizes toxicology safety studies on new drug substances. Improves methods for drug safety evaluation; analyzes and prepares reports of findings; performs advisory functions in dealing with items found to contain toxic material; and completes and/or reviews toxicology section of submissions to regulatory agencies. -Senior Scientist I:Independently conceives and executes experiments that implement project strategy and test independently‐ generated hypotheses. May bring new technique(s) into lab/ process.
Increasingly proficient at supporting multiple activities in parallel. Provides input to operational and/or strategic discussions related to own technical knowledge. Job Description Major accountabilities: Senior Scientist I:Designs/executes experiments and identifies next steps based on analysis of own data and data from other lab contributors.
Independently modifies existing lab techniques/processes and implements techniques new to the lab. Communicates results and conclusions to project meetings. May provide input to internal/ external publications including writing relevant sections.
Skilled in collaboration across project team labs. May suggest/build new network connections within existing project teams. Routinely trains members of lab and broader project team in familiar techniques.
Expected (if needed) to undertake organizational responsibility (such as equipment power user, lab safety rep). Accountable for increasingly complex experiments; key contributor to the success of drug discovery, technology, and/or early development projects. Brings ideas from a concept or question to a decision in experimental design, based on previous observations.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt Minimum Requirements: Graduate/ Postgraduate in Life Sciences with 5-7 years relevant experience working in pharmaceutical GLP setting. Good working knowledge of regulatory compliance requirements Knowledge of animal welfare requirements related to study conduct Good communication skills, and excellent logistical/planning skills Previous experience with software for online information and program management is a plus Skills Desired Animal Models, Bioinformatics, Collaboration, Data Analysis, Ethics, Problem Solving, Regulatory Compliance, Toxicology