Labeling Coordinator

Overview: The Regulatory Affairs Labeling Coordinator is responsible for obtaining timely final printed labeling for submission to FDA and use by Purchasing. The Labeling Coordinator obtains final printed labeling by communicating with the Regulatory Affairs, Marketing and Quality Assurance personnel responsible for each particular product, serving as the contact with vendors responsible for lay out and printing, preparing a CD with final printed labeling (container labels and outserts) for FDA submission, and communicating with Purchasing regarding FPL ordering. The Labeling Coordinator also initiates changes to FPL and circulation of the internal change controls. Depending on knowledge and experience, also may be involved in regulatory approval of labeling.Responsibilities:
Responsible for timely production of final printed labeling and implementation of post-approval labeling changes. Communicate with RA personnel and vendors to obtain compliant container labels, outserts, and patient information; proofread FPL to ensure accuracy; manage labeling change controls.Maintain organized labeling files and provide labeling samples to RA personnel and other departments as needed. Maintain timelines of ongoing labeling projects for reference by RA personnel and to ensure timely completion.
Serve as labeling contact for internal departments such as Marketing, Purchasing, and QA.
Special projects as directed.Job Requirements
Qualifications:
Bachelor’s Degree; or Associate’s Degree and at least 5 years executive assistant experience; or Associate’s Degree and at least 10 years administrative experience
At least 1 year experience in pharmaceutical or related industry.
Proficiency in Word.
Excellent organizational skills and attention to detail.
Extensive proofreading experience.
Ability to handle multiple projects.
Good communication skills.
Experience in meeting strict timelines.
Ability to work with minimal supervision.