Amgen Regulatory Labeling Senior Manager in Thousand Oaks, California
Amgen is searching for a Regulatory Labeling Senior Manager to work in our main corporate campus in Thousand Oaks, CA. The Senior Manager will report to the Director Global Labeling Strategy.
As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, 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 Regulatory Labeling Senior Manager will manage the development of the Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s).
Responsibilities for the Regulatory Labeling Senior Manager include:
Authors (user friendly, international language, consistent across products) and maintains core labeling documents including Company Core Data Sheet (cCDS), Core Patient Information Leaflet (cPIL), Core Instructions for Use (cIFU), Development Core Data Sheet (dCDS), Development Core Instructions (dIFU) for Use, and United States Prescribing Information (USPI) and medguide.
Manages compounds with a high degree of complexity from a labeling perspective.
Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
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.
Provides input and strategic guidance to Target Product Labeling.
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.
Incorporates feedback from HF studies into the cIFU and associated labeling.
Works with customer experience, packaging engineering, and branding, HF, and artwork center to create layout templates for use in HF studies.
Support HF studies in evaluation of participants output during the studies.
Manages the review and approval of core Dear Health Care Provider (DHCP) letters.
Represents labeling on product-specific global regulatory teams.
Domestic and international travel 10%
Doctorate degree and 2 years of Labeling or Regulatory Affairs experience
Master's degree and 4 years of Labeling or Regulatory Affairs experience
Bachelor's degree and 6 years of Labeling or Regulatory Affairs experience
Associate's degree and 10 years of Labeling or Regulatory Affairs experience
High school diploma / GED and 12 Labeling or Regulatory Affairs experience
Experience in Pharmaceutical Industry and product labeling
Knowledge of FDA, EMA, and other international regulations for labeling
Project Management Skills
An understanding of the impact of emerging trends and their implications for Amgen
Experience in managing individual and group projects of high to moderate complexity
Knowledge of global labeling regulatory requirements, standards and processes
Experience with product development, and a solid understanding of biology and pharmacology relevant to the therapeutic area
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
Strong collaboration, presentation, communication, and leadership skills
Attention to detail, project management time management, organizational skills
Excellent project management, verbal, and written communication skills
Experience working in a Documentum-based document management system
Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.