Amgen

Regulatory Labeling Senior Manager (Oncology)

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 08, 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).

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our "people-first" philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

Consistent with our core leadership value of "Develops the Best Team," we are seeking leaders that prioritize the development of talent. As a manager, your first priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development. Ways that you will display your leadership acumen in this role include:
  • Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
  • Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
  • Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business
  • Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
  • Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
  • Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans


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.

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.