Data Entry Clerk

Job Title: Document Coordinator

Location: New Brunswick, NJ

Duration: 6 Months

This is a Onsite Role

Bachelor's degree required

Job Description:

Work Schedule: Monday - Friday, Business Hours

Responsibilities:

• 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 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

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.Education:

• Bachelor's degree required in a Business-Related field

Job Type: Contract

Salary: $20.00 - $23.73 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

COVID-19 considerations:
Candidate has to be fully vaccinated.

Work Location: One location