Document Coordinator, Product Integrity/Toxicology

ROLE AND RESPONSIBILITIES:

Reporting to the Senior Director Product Integrity and Toxicology, the Document Coordinator is responsible for tasks associated with the control and storage of internal documentation, as well as suppling copies for domestic and international regulatory submissions. Job duties include document filing, preparation, tracking, processing, and adherence to internal quality procedures. The successful candidate will provide organizational, administrative, and communication support in the following areas.

• Demonstrate an understanding of document control process and procedures, including electronic and hard copy format.
• Ensure all documents are current and updates and new releases are executed in a timely and accurate manner.
• Support internal and external audits to maintain appropriate records
• Maintain controlled documents and records by updating folders, databases and spreadsheets.
• Index/inventory documents including, but not limited to, study setup information, spreadsheets, nonclinical protocols, nonclinical reports.
• Perform related duties as assigned, within your scope of practice

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

• Requires a minimum of 1-3 years related experience in a regulated environment.
• Requires strong attention to detail to ensure accurate information is provided throughout the organization.
• Expected to have excellent verbal and written communication skills.
• Able to navigate, conduct searches, and complete online forms for the purposes of training, performance management, and self-service applications.
• Demonstrated ability to work collaboratively with people from a wide range of backgrounds.
• Must have experience with Microsoft Office Applications, G-Suite Applications, and electronic databases, VEEVA Vault experience a plus.

EDUCATION:

• Preferred, bachelor’s degree in a science or business or relevant work experience.