Regulatory Labeling Strategist, Manager

Career Category

Job Description

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 Strategist, Manager

Live

What you will do

Let’s do this. Let’s change the world. As part of Global Labeling Strategy, and under the supervision of the Labeling Strategy Therapeutic Area Head for Inflammation and Rare Disease, the Regulatory Labeling Strategist is responsible for driving labeling strategy, developing, maintaining, and updating labeling documents, and supporting the facilitation and management of the end-to-end labeling processes for pre- and 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 United States labeling for assigned products in accordance with the product strategy and Amgen labeling processes.

Principal responsibilities include:

• Authors target product labels in collaboration with the Global Regulatory Lead and other cross-functional team members.
• Authors, updates, 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.
• Authors, updates, and maintains US labeling documents (including US prescribing information, medication guide, patient package insert, instructions for use).
• Chairs/leads the cross-functional labeling team (Label Working Group) to obtain alignment and endorsement of new and updated labeling documents.
• Presents to cross-functional and executive level management (Executive Labeling Board) to obtain endorsement, as appropriate, for proposed core and US labeling.
• Serves as a labeling strategy subject matter expert, providing teams with strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends across the organization.
• Represents labeling on product-specific Global Regulatory Teams (GRTs).
• 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, evaluates, and approves deviations of local product labels from core or reference labeling; ensures deviations from labeling procedures and policies are addressed and escalated, as appropriate.
• Supports preparation of responses to labeling-related Health Authority queries
• Supports the continuous improvement of initiatives across the End to End labeling process.
• Manages the review and approval of core Dear Healthcare Provider letters
• Contributes to annual reports, routine safety reports, and product quality complaint evaluations.

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:

Required Education

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

Required Knowledge and Skills

• Knowledge of global labeling regulatory requirements, standards, and processes
• Understanding of product development, and a solid understanding of biology and pharmacology relevant to the therapeutic area
• Analytical thinking
• Ability to develop solutions that are thorough, practical, and consistent with functional objectives
• Strong collaboration, interpersonal and negotiation skills
• Demonstrable conflict resolution and negotiation skills
• Meeting facilitation and presentation skills
• Strong attention to detail, time management, and organizational skills
• Excellent verbal and written communication skills
• Strong technical writing skills
• Proficiency utilizing Microsoft Suite – Outlook, Word, Excel, PowerPoint

Preferred Qualifications:

• Degree in pharmaceuticals, life science, or medicine
• Demonstrated experience with authoring, developing, and updating pharmaceutical, biotechnology, and/or device product labeling
• Labeling or regulatory affairs experience in various therapeutic areas
• Understanding of the impact of emerging labeling 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 document 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. 

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. 

• 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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In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Salary Range