Labeling Development Manager

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. The purpose of this position is to support packaging, manufacturing, and distribution activities through the development, maintenance, and control of labeling and labeling support documentation. This position will support the assimilation of proposed labeling text changes and the creation of new labeling components when required. Primary end result will be error free artwork, printed component specifications, and possibly Bills of Materials (BOMs) for all labeling for Baxter products worldwide, provided in a timely manner to support manufacturing requirements while maintaining strict adherence to Baxter Standard Operating Procedures and cGMP guidelines. ESSENTIAL DUTIES AND RESPONSIBILITIES Assign Documentation Associates to and assist with the preparation of new and revised labeling components by gathering all necessary change information from other departments including: Marketing, Package Engineering, Regulatory Affairs, Quality Assurance, and any other required functions. Approve all artwork, printer's proofs, and specifications for consistency with approved labeling text and/or Baxter specifications. Maintain accurate status of all labeling components under development. Follow up with reviewers/printers/others when necessary. Participate on product launch teams to meet submission and launch requirements for Label Development. Guide Documentation Associates in writing Graphic Service Requests, timing, approval, and daily issues. Update and maintain departmental Standard Operating Procedures (SOPs). QUALIFICATIONS: 5 Year's experience in development of Pharmaceutical labeling experience. Knowlege of cGMP's and FDA labeling regulations for Pharmaceuticals. Associate's or Bachelor's degree, preferably in a technical area. Accuracy and attention to detail. Strong administrative and organization skills. Excellent communication skills are required for interfacing at all levels within Baxter, working with outside vendors, external customers/distributors/manufacturers, and direct reports.   Understanding of manufacturing requirements, print vendor requirements, and customer needs. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.