Amgen Regulatory Labeling Manager in Thousand Oaks, California
The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents to provide quality product labels 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 (GL), and under the supervision of the oncology Therapeutic Area Lead, the Labeling Strategist, Manager is responsible for the facilitation and management of the end-to-end labeling processes for pre and post marketed products over the product life cycle. The Regulatory Labeling Manager will manage the development of the Core and US labeling documents in accordance with Amgen labeling processes for assigned therapeutic area(s).
Responsibilities for the Regulatory Labeling Manager include:
Authors and maintains core labeling documents including Core Data Sheet (CDS), core Patient Information Leaflet (cPIL), core Instructions for Use (cIFU), development Core Data Sheet (dCDS), development Core Instructions for Use (dIFU), and United States Prescribing Information (USPI).
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 the Target Product Label.
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 Human Factors (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.
Supports 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%
Master's degree and 2 years of Pharmaceutical/Biotech or CRO industry experience
Bachelor's degree and 4 years of Pharmaceutical/Biotech or CRO industry experience
Associate's degree and 10 years of Pharmaceutical/Biotech or CRO industry experience
High school diploma / GED and 12 years of Pharmaceutical/Biotech or CRO industry experience
Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering
Accomplish business results through teams
Proficiency in anticipating and resolving problems
Use of document management tools
Ability to develop relationships and work well with others in demanding situations with a positive attitude
Time and project management skills
Ability to take initiative and drive results
Tolerance for ambiguity
Oral and written communication and presentation skills
Degree in pharmaceuticals, natural science or medicine
Previous experience working in industry in support of global labeling
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.