Global Labeling Strategy Sr. Manager - TA Head

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Global Labeling Strategy Sr. Manager - TA HeadLive

What You Will Do

Lets do this. Lets change the world. 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 Therapeutic Area Lead, reporting to the Head of Global Labeling, directs and leads the Labeling Strategists within a Therapeutic Area (TA). In this vital role, you will be 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.

Responsibilities Will Include

• Global labeling strategy development and implementation
• Ensuring accuracy and consistency in the development review, approval and maintenance of core product labeling documents
• Global review and approval of regional deviations from core content
• Organization of all global and cross-functional activities related to the labeling content processes
• Provide expert interpretation of international regulations affecting global labeling
• Directs strategic content for Labeling within a TA (including dCDS/cCDS, dIFU/cIFU, cPIL, 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 critical issues 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
• Implements 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
• Travel requirement 10%
  
  
  

Win

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications

Doctorate degree and 2 years of related experience

Or

Masters degree and 4 years of related experience

Or

Bachelors degree and 6 years of related experience

Or

Associates degree and 10 years of related experience

Or

High school diploma / GED and 12 years of related experience

Preferred Qualifications

• Degree in pharmaceuticals, natural science or medicine
• Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
• Experience in the development and maintenance of core and product Labeling
• Comprehensive knowledge of international regulations related to product labeling
• Strong understanding of scientific principles relevant to drug development and product 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 get results
• Ability to manage through ambiguity
  
  
  

Thrive

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible
  
  
  

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.comApplication deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.