Job description

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 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

Experience:

• 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

Additional Job Requirements:

• Position Handles Hazardous Materials

Job Type: Full-time

Salary: $21.00 - $23.74 per hour

Benefits:

• Dental insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Columbus, OH 43207: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Speak with the employer
+91 609-796-9502

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