Global Labeling Strategy Sr. Manager - TA Head

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Labeling Strategy Sr. Manager - TA HeadLive

What you will do

Lets do this. Lets change the world. The purpose of the Global Labeling (GL) group is to develop and maintain core 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.

The Therapeutic Area Lead, reporting to the Head of Global Labeling, directs and leads the Labeling Strategists within a Therapeutic Area (TA). In this vital role, you will be a member of the Global Labeling Leadership Team, with accountability for the strategic labeling content within a Therapeutic Area, over the product(s) life cycle.

Responsibilities will include:

• Provides strategic guidance on global labeling regulations, requirements, competitor labeling, and labeling trends to support optimal proposals for agency submission and provides input and leads the strategic guidance as part of early label development (i.e., Target Product Labeling)
• Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings (Labeling Governance) for review of core and US labeling documents.
• Leads/Responsible for the development, management and maintenance of core labeling documents (e.g., Core Data Sheet (CDS),)and regional US labeling documents (i.e. Prescribing Information).
• Leads the preparation and finalization of labeling deliverables during labeling negotiations.
• Represents labeling on product-specific global regulatory teams and informs on GRT decision which impact any relevant portfolio assets including preparation of responses to labeling-related Health Authority queries
• Consults/Collaborates on tangible solutions to labeling strategy and related issues with Labeling Strategist assign to therapeutic area (TA) and other across Tas.
• Supervises direct reports and supports their career development

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 and 2 years of related experience

Or

Masters degree and 4 years of related experience

Or

Bachelors degree and 6 years of related experience

Or

Associates degree and 10 years of related experience

Or

High school diploma / GED and 12 years of related experience

Preferred Qualifications:

• Life science Degree or 5 Years in Pharma Regulatory Affairs submission execution experience (as individual contributor)
• Demonstrated experience in Global Regulatory Affairs Pharma and/or Labeling (content)
• Strategy management (core and regional pharma regulatory labeling). Experience with Veeva RIM preferred.

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.

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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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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