Amgen

Regulatory Labeling Senior Manager (Oncology)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 24, 2019
Ref
R-66782
Required Education
High School or equivalent
Position Type
Full time
Amgen is searching for a Regulatory Labeling Senior Manager (Oncology) to work at our beautiful corporate campus in Thousand Oaks, CA.

As part of Global Labeling (GL) and under the supervision of the Oncology Therapeutic Area Head, the Regulatory Labeling Senior 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 Senior Manager will lead 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 Senior 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).
  • Runs compounds with a high degree of complexity from a labeling perspective.
  • Chairs/leads Labeling Working Group and presentations to Executive Labeling Board meetings.
  • Advises internal and/or external authorities on the creation of high quality documents supporting changes to the core labeling documents and leads 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 raised 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.
  • Leads 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%


Basic Qualifications:

Doctorate degree and 2 years of Labeling or Regulatory Affairs experience

Or

Master's degree and 4 years of Labeling or Regulatory Affairs experience

Or

Bachelor's degree and 6 years of Labeling or Regulatory Affairs experience

Or

Associates degree and 10 years of Labeling or Regulatory Affairs experience

Or

High school diploma / GED and 12 years of Labeling or Regulatory Affairs

Preferred Qualifications:
  • Experience in the Regulatory Affairs and Labeling, particularly in oncology
  • Knowledge of FDA, EMA, and other international regulations for labeling
  • An understanding of the impact of emerging trends and their implications for Amgen
  • Experience in leading 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
  • Analytical thinking
  • 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 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 uses 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.#LI-SF5

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.