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 https://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.
95,https://277.00 USD - 134,https://309.00 USD