Reference #: Req. # 782339 In Bayer's Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials. The primary responsibilities of this role, Sr. Manager, Global Device Labeling Strategy, are to: Act as subject matter expert in design controls, labeling SOPs, labeling standards / regulations to establish (with the Product Development Teams and relevant stakeholders) clear, concise, and valid product labeling requirements. Lead the development and delivery of all product labeling and labeling deliverables (design verification, design reviews, etc.) for a project and plays a key role in transitioning label design inputs into labeling design outputs. Drive alignment with product supply, Regulatory Affairs, and R&D Stakeholders to establish, document, and maintain the appropriate labeling implementation / configuration strategy. Provide direction to Labeling Specialists (internal and external) to ensure all requirements have been properly implemented and project timelines met; serving as SME for Content Management System, when applicable. Ensure labeling activities / deliverables are appropriate and sufficient to demonstrate requirements and stakeholder needs are satisfied. Partner with Regulatory Affairs, Human Factors Engineering, Marketing, and Clinical Affairs to ensure accurate representation of BAYER products to the end user through product labeling. Support the identification, planning, and implementation of continuous process improvement initiatives / activities. WHO YOU ARE Your success will be driven by your demonstration of our LIFE (Leadership, integrity, Flexibility, Efficiency) values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications: Bachelor's or master's degree in engineering, science, graphic design, technical writing, English or related field. Preferred Qualifications: Minimum 8 years of professional experience within the Pharmaceutical, or Medical Device Industry.

Bayer is an Equal Opportunity Employer/Disabled/Veterans