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Title

Document Specialist 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
 
Full-Time/Part-Time Full-Time  
Description

Will work in hybrid environment

Possibility to be converted to a full-time role based on BIs needs and the workers performance.

Description:

Provide administrative support for the Animal Health Review Committee (AHRC) process and act as a liaison between AHRC, Marketing, Regulatory Affairs, Legal, and other involved parties in order to facilitate rapid and accurate review of all U.S. Animal Health advertising and promotional materials created by the US Pet Business.

Duties & Responsibilities:

Supervise promotional material projects (submissions) submitted for review and approval using Veeva Vault.

Monitor the progress of submissions to ensure timely review and approval.

Provide targeted, constructive feedback to project sponsors and advertisement agencies to ensure correct submission and completion of projects.

Review proposed final copies of submissions to ensure all required changes are addressed appropriately.

Provide recommendations and guidance to project sponsors and advertisement agencies when required changes are not addressed appropriately.

Responsible for ensuring final copies of submissions that include FDA-regulated products are delivered to Regulatory Affairs via Veeva Vault for final approval and submission to the FDA.

Skills:

Background in Veterinary Medicine, Marketing, Quality Assurance, Compliance, Project Management, and/or Advertisement and Promotional Material Review preferred.

At least two (2) years relevant or related work experience in an FDA regulated industry.

At least two (2) years of related document control experience in an FDA regulated industry with firm knowledge of formal document control systems, including quality assurance principles and procedures.

Proficient knowledge of animal health products.

Proficient computer skills with emphasis on Veeva Vault and Microsoft Suite programs.

Strong interpersonal, written, and verbal communication skills.

Exceptional organizational, analytical, and judgment skills.

Must be able to confidently and effectively work in a fast-paced, team environment.

Ability to work independently, cross-functionally and maintain effective working relationships with all departments including all levels of management.

Education:

Bachelor's degree from an accredited institution required. In lieu of degree, a minimum of five (5) years of relevant experience working in an FDA regulated industry is required.

 
Location Duluth, GA  

This position is currently not accepting applications.

To search for an open position, please go to http://pineytechnicalservices.appone.com



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