Toxicology Research Specialist

Job Summary: Participates in non-clinical site monitoring and data analysis. Also participates in review and finalization of non-clinical study reports. Researches and prepares relevant information on various topics in support of Director’s activities and other members of the toxicology group. Responsible for coordinating activities of consultants and in-house personnel to ensure contractual obligations are met. Generates reports to track budgets and project progress. Responsible for assuring compliance with SOPs and FDA and ICH regulations.Job Responsibilities: Creating tabular summaries of study reports for toxicology submissions and presentations by the department toxicologists Conducting literature searches related to development programs Preparing study report summaries for Annual Reports to IND and NDA submissions Review of IND, NDA, IB and BD submissions for technical differences and omissions Plotting/analyzing data from study reports Participating in data reviews and discussions of toxicology and program related issues Developing and maintaining databases and spreadsheets to track budgets and project progress. Communicate effectively with other departments in order to address questions from the Director and other members of the toxicology group Interact with Contracts Office to initiate Master Agreements and Work Orders Interact with CROs and consultants and respond to emails and correspondence Maintain files of toxicity study reports for each of the on-going development programs General activities as assigned by Director including travel arrangements, registering department staff for outside meetings and submitting Concur expense reports Other duties as assigned by Director
REQUIREMENTS
Job Requirements: BA/BS in biosciences or equivalent experience. Familiarity with pharmaceutical development is essential. Knowledge of toxicology and toxicology related issues is useful. Familiarity with pharmacokinetic/toxicokinetic analysis, as well as a working knowledge of non-clinical design is helpful. Must have good interpersonal skills and written and verbal communication skills. Must be experienced in use of a variety of computer software (e.g., Word, Excel, Power Point, Sigma Plot)
Skills: Clinical Case Study Reports, Clinical Study Status Reports, Food & Drug Administration FDA Reports, ICH Guidelines, Investigational New Drug IND Application, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Monitor Clinical Study Sites, New Drug Application NDA, Verbal Communication Skills, Written Communication Skills