Job Description
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Labeling Strategist Manager What You Will Do Lets do this. Lets change the world. The purpose of the Labeling Strategy and Compliance (LSC) group is to develop and maintain quality core and regional labeling documents and drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world. As part of Global Labeling Strategy and Compliance (LSC), and under the supervision of the Therapeutic Area Obesity and Related Conditions Assistant Vice President, the Labeling Strategist, Sr. Manager is responsible for the facilitation and management of the end-to-end labeling processes for pre & post marketed products over the products life cycle. The Labeling Strategist, Sr. Manager will lead the development of the Core Labeling documents and US Labeling deliverables in accordance with Amgen Labeling Processes for assigned therapeutic area(s). Responsibilities Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings. Leads the development and maintenance of core labeling documents including Core Data Sheet (CDS), core patient information leaflet (cPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and medication guide. Represents labeling on product-specific global regulatory teams and informs on GRT decision which impact any relevant portfolio assets, Provides input and leads the strategic guidance to Target Product Labeling, Manages compounds with a medium to high degree of complexity from a labeling perspective. Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends to other Labeling Strategist across the regulatory organization. Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents. Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies. Reviews and provides feedback and approves deviations from core labeling. Ensures deviations from labeling procedures and policies are escalated appropriately. Assists in preparation of responses to labeling-related Health Authority queries. .Manages the review and approval of core DHCP letters. Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews. Collaborates on provides tangible solutions to labeling issues. Supervises direct reports and supports their career development, if applicable. Represents labeling on product-specific global regulatory teams. Amount of travel required 10% as needed, Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, and industry standards. Knowledge of global labeling regulatory requirements, standards and processes. Demonstrated understanding of product development is required, and a comprehensive understanding of biology and pharmacology relevant to the therapeutic area. Analytical thinking and critical judgment. Ability to work and manage multiple assignments and timeline driven priorities. Substantial project management skill, with demonstrated ability in planning, implementing, and executing tasks to meet RA goals. Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives. Demonstrated ability to lead teams. Interpersonal, organizational and negotiation skills. Strong technical writing skills.