- Entry level
- No Education
- Salary to negotiate
- Thousand Oaks
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
Doctorate degree and 4 years of experience in the Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
Master’s degree and 8 years of experience in the Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
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
Degree in pharmaceuticals, natural science or medicine
Experience in the development and maintenance of core and product Labeling
About the company
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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