Labeling Strategy Manager

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

What you will do

Lets do this. Lets change the world. As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Regulatory Labeling Manager will support oncology and 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).

• 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).

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 [type of person] with these qualifications.

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

High school diploma / GED and 12 years of related experience

• 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

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, 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.

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.