Data Entry Clerk

Responsibilities

• Cook up and approve nonclinical protocols, reports, and regulatory submission documents via the electronic data management system.
• Ensure all nonclinical documents are properly formatted and edited for submission readiness.
• Create nonclinical tabulated summaries for global regulatory submissions.
• Conduct comprehensive quality control checks (QC) for nonclinical content within regulatory submission documents.
• Ensure all work complies with Standard Operating Procedures, Good Laboratory Practice regulations, and study protocols.
• Prepare and publish routine and complex Company/DT regulatory documents according to established processes.
• Aid in record management activities within the Nonclinical Archive, including inventory management, reconciliation, archiving, and retrieval.
• Handle hazardous materials as part of toxicology studies.

Requirements

• Two to four years of experience in nonclinical science or a related discipline.
• Knowledge of the nonclinical study process, preparation, and processing of regulatory documents for product registration.
• Proficiency in electronic dossier management systems, such as Documentum.
• Expertise in Microsoft Word, Access, Excel, and Adobe Acrobat.
• Exceptional proofreading and attention to detail.
• Effective communication and teamwork skills.

Qualifications

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

Skills

• Electronic dossier management.
• Documentum.
• Microsoft Word/Access/Excel/Adobe Acrobat.
• Proofreading and attention to detail.
• Communication and teamwork.

Benefits

• Flexible schedule: 8-hour shifts, Monday to Friday.

Pay

$20.00 - $23.73 per hour.

Schedule

Day shift.

COVID-19 Considerations

Candidate must be fully vaccinated.

Work Location

One location.