Oncology Labeling Director

Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms - Bispecific T Cell Engagers (BiTE®s), CARTs, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules - across many targets and more than a dozen tumor types.

Amgen is seeking an Oncology Labeling Director who will be located at our Thousand Oaks, CA campus.

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.

The Oncology Labeling Director, reporting to the Head of Global Labeling, directs and leads the Labeling Strategists within a Therapeutic Area (TA). The Oncology Labeling Director is a member of the Global Labeling Leadership Team, with accountability for the strategic labeling content within a Therapeutic Area, over the product(s) life cycle.

Specific responsibilities of the Oncology Labeling Director include:

• Accountable for global labeling strategy development and implementation
• Accountable for ensuring accuracy and consistency in the development review, approval and maintenance of core product labeling documents
• Accountable for the global review and approval of regional deviations from core content
• Accountable for the organization of all global and cross-functional activities related to the labeling content processes
• Is the expert on interpretation on global regulations affecting global labeling

Principal responsibilities include, but are not restricted to:

• Directs strategic content for Labeling within a TA (including dCDS/cCDS, dIFU/cIFU, cPIL, TPL, maintenance agreements, and other core components)
• Accountable for strategic and tactical guidance to product labeling review teams regarding labeling development and maintenance of corporate labeling documents
• Accountable to partner with Human Factors and Quality Engineers to ensure comprehensive and competitive IFUs within Design Control procedures
• Ensures labeling processes support the development of accurate, current consistent, comprehensive and competitive global labeling
• Reviews and comments on the internal and external guidelines and regulations related to regulatory, safety, and legal topics
• Accountable for ensuring compliance with global regulatory requirements and adherence to internal regulatory policies and processes
• Provides advice and support to the Labeling Strategist on key labeling decisions or on escalation of decisions involving labeling review committees (e.g. Labeling Working group, Executive Labeling Board or Senior Management Team)
• Chairs the Executive Labeling Board
• Provides input and strategic guidance to the Target Product Label
• Executes goals aligned with department strategies and plans
• Represents global labeling during audits and inspections
• Independently makes decisions regarding complex operations, processes or business practices
• Supports creation and administration of department/labeling training programs.
• Leads or participates in internal and external (cross functional or health authority/industry) special projects (improvement initiatives, strategic planning, and labeling guidance documents)
• Educates and influences senior and peer staff on Global Labeling approaches and processes
• Accountable for performance management of labeling team members with an expectation to grow the group as required and ensure Amgen has the best talent in the industry
• Mentors and coaches direct reports
• Accountable for hiring and succession planning of staff
• Accountable for workload and resource distribution within a TA

Basic Qualifications

Doctorate degree and 4 years of experience in the Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling

OR

Master's degree and 8 years of experience in the Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling

OR

Bachelor's degree and 10 years of experience in the Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling

AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Degree in pharmaceuticals, natural science or medicine
• Experience in the development and maintenance of core and product Labeling
• Significant knowledge of international regulations related to product labeling
• Strong understanding of scientific principles relevant to oncology drug development and labeling
• Organizational expert within defined subject area
• Experience in Medical Device industry, including Design Controls and Human Factors principles
• Experience with combination products/drug delivery systems
• Knowledge of FDA, EMA, and other international regulations for labeling
• Understands impact of emerging trends and their implications for Amgen
• Management oversight of complex projects
• Advanced knowledge of labeling regulations with particular focus on the regulatory environment in global markets
• Understanding of product development, and science relevant to the therapeutic area
• Understanding the impact of emerging labeling requirements and their implications for Amgen
• Analytical thinking, demonstrated ability to anticipate and solve problems by providing alternative solutions prior to escalation of issues to management
• Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
• Demonstrated ability to accomplish business results through teams
• Strong collaboration, presentation, communication, interpersonal, and leadership skills
• Influencing, negotiation and decision-making skills
• Ability to take initiative and drive results
• Ability to manage through ambiguity

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.