Labeling Coordinator

Bayer Animal Health is a world leading innovation-driven veterinary pharmaceutical company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Bayer Animal Health operates in more than 100 countries worldwide and is wholly part of Bayer Group internationally.Bayer is seeking an individual to manage the following duties:Initiate and coordinate the label approval process to authorize labeling production for all products processed and/or sold by the Animal Health Division through the creation and modification of product text and graphic information. Verify necessary information for production of every labeling component for Bayer Animal Health and its contract products. Continuously improve the approval processes for labeling to reduce lead-time, and enhance the company’s competitive position by increasing flexibility in meeting market opportunities. Ensure orderly and efficient utilization of manpower and resources to meet all Bayer Animal Health standards as well as standards required by the Federal government (FDA, EPA and DOT). Liaison between multiple departments and external vendors assuring that all internal and external customer requirements are met.1. Coordinate label and package requirements of the Regulatory, Manufacturing, Purchasing, Package Development, Production and Technical Services departments to ensure accurate and timely delivery of product to the market. This includes the label information to customers and regulatory agencies as well as information on the product package for all Animal Health and contract manufactured products.2. Work in compliance with requirements of FDA, EPA, DOT and foreign government agencies. 3. Coordinate with appropriate internal, or external, Regulatory Affairs Department to ensure clear and concise labeling that is scientifically sound and meets Bayer HealthCare and government standards. Advocate any changes of benefit to Bayer HealthCare LLC and the industry.4. Coordinate creation of all labeling artwork for decorated packaging, meeting the specifications established by Regulatory, Advertising, Marketing, Package Development, Traffic, and foreign agencies in addition to meeting the production schedule defined by Production Planning and/or Contract Manufacturing.5. Ensure timely delivery of accurate labeled packaging for product production.6. Coordinate project activities to create or revise correct artwork while minimizing the lead-time required for developing artwork.7. Responsible for quality assurance of labeling development and approvals, including master artwork with back-ups, and for ensuring that up-to-date notifications and Label Approval Sheets are available to the appropriate departments.8. Develop and maintain a History File of: 1) in-process, 2) completed, and 3) archived artwork in accordance with Standard Operating Procedures (SOP’s).9. Review and approve artwork, and proofs of plates, to ensure compliance with specifications established by the appropriate Regulatory, Marketing, Package Development, Manufacturing, Traffic Departments, foreign entities, and printers.10. Maintain the Labeling History files to track the history of all product labeling for FDA purposes.11. Conduct vendor audits and press checks as needed to ensure the quality printing of our product labeling.Requirements:• Bachelors degree plus minimum of 3 years experience in the pharmaceutical industry or minimum of 5 years experience in the pharmaceutical industry, without a degree.• Sound working knowledge of generally accepted graphic art principles which include typography, line art layout, color film, separations and related skills, preferred• Highly proficient in project management, multitasking and extremely detailed oriented • Basic working knowledge and understanding of regulations by government agencies affecting the pharmaceutical industry is desirable• Familiarity with labeling components and veterinary pharmaceutical products is beneficial• Must be a self-starter and detail-oriented and creative• Strong organizational skills, and oral and written Excellent interpersonal skills• Proficiency in Word, Excel, Adobe, and general knowledge of graphic artExcellent company benefits package. Qualified candidates should apply at www.bayerjobs.com, Animal Health, Job #5655.BAYER ANIMAL HEALTH is an Equal Opportunity Employer; M/F/Disabled/Vet. Bayer is committed to enhancing and maintaining cultural diversity within our work environment..