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Regulatory Labeling Mgr

Company: Amgen
Location: Thousand Oaks
Posted on: September 19, 2019

Job Description:

Amgen is seeking a Regulatory Labeling Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position: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 Inflammation/Nephrology/Biosimilars Therapeutic Area Lead, the Labeling Strategist, Manager is responsible for the facilitation and management of the end-to-end labeling processes for platform, pre- and post- marketed products over the product life cycle. The Regulatory Labeling Manager will manage Core, US and Platform 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 plansResponsibilities 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), United States Prescribing Information (USPI), and platform Instructions for Use (pIFU).
    • Chairs/leads Labeling Working Group and presentations to 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 approves deviations from core and platform 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, pIFU, and associated labeling.
    • Works with customer experience, packaging engineering, 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% Basic Qualifications Doctorate degreeORMaster's degree and 3 years of Pharmaceutical/Biotech or CRO industry experienceORBachelor's degree and 5 years of Pharmaceutical/Biotech or CRO industry experienceORAssociate's degree and 10 years of Pharmaceutical/Biotech or CRO industry experienceORHigh school diploma / GED and 12 years of Pharmaceutical/Biotech or CRO industry experiencePreferred Qualifications BS Degree in natural sciencePrevious experience working in industry in support of Global Labeling or Regulatory AffairsAccomplishing business results through teamsProficiency in anticipating and resolving problemsHigh level of proficiency in Word, Excel and PowerPoint, and use of document management toolsAbility to develop relationships and work well with others in demanding situations with a positive attitudeTime and project management skillsAbility to take initiative and drive resultsTolerance for ambiguityOral and written communication and presentation skillsAmgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.Amgen focuses on areas of high unmet medical needs 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.Join UsIf 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 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 statusJoin UsIf 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.

Keywords: Amgen, Arcadia , Regulatory Labeling Mgr, Other , Thousand Oaks, California

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