United States onlyCareer Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Labeling Strategist, Manager
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 Therapeutic Area Lead, the Labeling Strategist, Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre & post marketed products over the products life cycle. The Labeling Strategist, Manager will support the development of the Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s).
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will [top-line statement connecting primary position responsibility to employer brand].
Principal responsibilities include, but are not restricted to:
- Authors (user friendly, international language, consistent across products) and maintains core labeling documents including cCDS, cPIL, and cIFU in addition to dCDS, dIFU, USPI, and medguide
- Chairs/leads the Labeling Working Group, and presents to Executive Labeling Board
- Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends
- Advises internal and/or external specialists on the creation of high quality documents supporting changes to the core labeling documents and runs 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.
- Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
- Represents labeling on product-specific global regulatory teams
- Amount of travel required 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 go-getter with these qualifications.
Basic Experience:
Doctorate degree
OR Master’s degree and 2 years of related experience
OR Bachelor’s degree and 4 years of related experience
OR Associate’s degree and 10 years of related experience
OR High school diploma / GED and 12 years of related experience
Peferred Experience:
- Degree in pharmaceuticals, natural science or medicine
- Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
- Knowledge of labeling within a Therapeutic Area
- Knowledge of FDA, or EMA, or other international regulations for labeling
- Collaboration, presentation, communication, interpersonal, and leadership skills
- Experience working in a Documentum-based document management system
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.
- 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.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application 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.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.
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