Amgen Regulatory Labeling Manager (US-Remote) in Los Angeles, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Regulatory Labeling Manager
What you will do
Let’s do this. Let’s change the world. As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, Regulatory Labeling 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. In this vital role you will support the development of the Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s).
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
Provides consultation to 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 implementation of global regulatory labeling plans are aligned with global regulatory strategies
Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are addressed appropriately.
Assists in preparation of responses to labeling-related Health Authority queries
Works with customer experience, human factors to create layouts with appropriate placement, meaning and tone
Incorporates feedback from HF studies into the cIFU and associated labeling
Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
Support HF studies in evaluation of participants output during the studies.
Supports creation of target product labeling
Manages the review and approval of core DHCP letters
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 leader with these qualifications.
Master’s degree and 2 years of related experience
Bachelor’s degree and 4 years of related experience
Associate’s degree and 10 years of related experience
High school diploma / GED and 12 years of related 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
Understanding the impact of emerging trends and their implications for Amgen
Project Management experience, experience managing individual and group projects of moderate complexity
Strong collaboration, presentation, communication, interpersonal, and leadership skills
Experience working in a Documentum-based document management system
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 annual base salary range for this opportunity in the U.S. is $95,277 - $134,309.
In addition to the base salary, 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
for a career that defies imagination
Objects in your future are closer than they appear. 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 cancers, 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.