What are the responsibilities and job description for the Scientist, Toxicology position at Certara USA, Inc.?
Overview
About Certara
Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.
Our toxicologists are responsible for providing expertise into non-clinical and clinical development plans, toxicology (TK), clinical pharmacology and PKPD studies. Our Scientists support projects for Certara's clients by working in teams with other associates, expert modellers or statisticians, epidemiologists, health outcomes researchers, or drug development consultants. Qualified candidates will have the ability to work on a variety of projects and data types, and may provide oversight of associates.
Responsibilities
- Design programs to support INDs, NDA / BLAs and postregistration studies.
- Outline studies and in partnership with clients, identify CROs to run these studies; manage the study data / information analysis with our client for draft reports and finalize with client.
- Conduct literature searches and triage results
- Prepare content of regulatory documents for filing.
- QC content of regulatory documents
- Assist toxicology lead(s) in preparing client response to any regulatory inquiries related to nonclinical studies.
- Support toxicology lead(s) on cross-functional drug development teams.
Qualifications
Skills & Abilities :
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
