New Brunswick, NJ
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 documents
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 NCS/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, record retrieval, record relocation
Potential to handle hazardous material
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 product registration
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 teams.
Bachelor's degree required in a Business-Related field
Additional Job Requirements:
Position Handles Hazardous Materials
Job Types: Full-time, Contract
Salary: $22.00 - $23.50 per hour
8 hour shift
Weekly day range:
Monday to Friday
Are You Fully Vaccinated?
Customer service: 5 years (Required)
Call center: 4 years (Required)
Pharmaceutical: 3 years (Required)
Bilingual English and Spanish: 3 years (Required)
Work Location: One location