Location: New Brunswick, NJ
Duration: 6 Months
This is a Onsite Role
Bachelor's degree required
Work Schedule: Monday - Friday, Business Hours
Coordinate the author, review, and approval of nonclinical protocols, reports, and regulatory submission
documents through the electronic data management system
Ensure proper formatting and editing of nonclinical documents to ensure submission-ready publishing
Create nonclinical tabulated summaries for global regulatory submissions
Perform comprehensive quality control checks (QC) for nonclinical content within regulatory submission
Track the status of assigned nonclinical document timelines
Ensure all work is in compliance with appropriate Standard Operating Procedures, Good Laboratory Practice
regulations, and study protocols in conducting toxicology studies.
Perform all aspects of electronic preparation and publishing of routine and complex Company/DT regulatory
documents following established processes.
Assist in record management activities within the Nonclinical Archive in compliance with standard operating
procedures. Activities may include record inventory management and reconciliation, record archival, recordretrieval, record relocation
Potential to handle hazardous materialExperience:
2-4 years experience in the conduct and reporting of nonclinical science, or related discipline
Knowledge of the nonclinical study process, preparation and processing of regulatory documents required for the
Knowledge of electronic dossier management, Documentum, Microsoft Word/Access/Excel, and Adobe Acrobat.
Excellent proof-reading skills and attention to detail.
Ability to effectively communicate and interact with co-workers at all levels and to work independently and on
Bachelor's degree required in a Business-Related field
Job Type: Contract
Salary: $20.00 - $23.73 per hour
8 hour shift
Monday to Friday
COVID-19 considerations:Candidate has to be fully vaccinated.
Work Location: One location