Labeling Strategist, Manager (US : Remote)
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 pharmaceutical 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
Lets do this. Lets 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%
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 Masters degree and 2 years of related experience
OR Bachelors degree and 4 years of related experience
OR Associates degree and 10 years of related experience
OR High school diploma / GED and 12 years of related experiencePeferred 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
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
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 a 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 an accommodation.
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, 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.
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.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.