Job Information
Amgen Regulatory Labeling Manager in Washington D.C., District Of Columbia
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
Live
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, the 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 product's life cycle. In this vital role you will author, enable internal governance reviews and manage the development of the Target Product Label, Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s).
Principal responsibilities include:
Authors and maintains core company labeling documents (including Core Data Sheet, Core Patient Information Leaflet, and Core Instructions for Use) in support of global marketing applications and variations.
Leads the cross-functional Labeling team as a Labeling Strategy subject matter expert for the creation and update of labeling - for alignment and communication of labeling text at product launch.
Authors US labeling documents (including USPI, Medication Guide, PPI, IFU) for the initial Marketing Authorization Application and updates for new indications, efficacy data, product quality changes and safety related topics. Presents to cross-functional and executive level management to obtain endorsement, as appropriate, for the proposed core document and US labeling text.
Leads cross-functional teams (Labeling Working Group) to align on the proposed core document and US labeling text.
Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends across the organization.
Provides consultation to internal and/or external experts on the creation of high quality core labeling documents and manages the dossier annotations within the 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.
Supports preparation of responses to labeling-related Health Authority queries
Incorporates feedback from HF studies into the cIFU (e.g., with incorporation of participants output during the formative/summative studies into the labeling) and associated combination product labeling
Supports the continuous improvement of initiatives across the End to End labeling process.
Supports creation of target product labeling.
Manages the review and approval of core DHCP letters
Regulatory Labeling core member/SME on product-specific Global Regulatory Teams (GRT).
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
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
Preferred Qualifications:
Demonstrated experience in authoring, developing, and updating Pharmaceutical or Biotechnology product prescribing information labeling
Degree in pharmaceuticals, life science or medicine
Knowledge of prescribing information labeling development within various Therapeutic Areas
Knowledge of FDA, or EMA, or other international regulations for prescribing information labeling with 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 Veeva-based RIM Regulatory 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.
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.
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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.
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