QC DOCUMENT COORDINATOR I NEW BRUNSWICK, NJ Onsite.
Required Skills:
Bachelor's degree required in a Business-Related field.
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 in teams.
Project Description:
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.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jacqueline: jacqueline@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00551
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
