Our client, a leading pharmaceutical company, is hiring a Document Coordinator consultant on a contract basis.
New Brunswick, NJ
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