Labeling Strategist

Career Category

Regulatory

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team.

What you will do

In this vital role you will develop and maintain quality core and regional labeling documents and drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.

As part of Global Labeling Strategy and Compliance (LSC), and under the supervision of the Therapeutic Area Obesity and Related Conditions Assistant Vice President, the Labeling Strategist, Sr. Manager is responsible for the facilitation and management of the end-to-end labeling processes for pre & post marketed products over the product’s life cycle. The Labeling Strategist, Sr. Manager will lead the development of the Core Labeling documents and US Labeling deliverables in accordance with Amgen Labeling Processes for assigned therapeutic area(s).

Responsibilities

• Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
• Leads the development and maintenance of core labeling documents including Core Data Sheet (CDS), core patient information leaflet (cPIL), and core instructions for use (cIFU) and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and medication guide.
• Represents labeling on product-specific global regulatory teams and informs on GRT decisions which impact any relevant portfolio assets.
• Provides input and leads the strategic guidance to Target Product Labeling.
• Manages compounds with a medium to high degree of complexity from a labeling perspective.
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends to other Labeling Strategists across the regulatory organization.
• Advises 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 execution of global regulatory labeling plans are aligned with global regulatory strategies.
• Reviews, provides feedback on and approves deviations from core labeling.
• Ensures deviations from labeling procedures and policies are escalated appropriately.
• Assists in preparation of responses to labeling-related Health Authority queries.
• Manages the review and approval of core DHCP letters.
• Contributes to Annual Reports / DSURs / PBRERs / Product Quality Complaint reviews.
• Collaborates on and provides tangible solutions to labeling issues.
• Supervises direct reports and supports their career development, if applicable.
• Amount of travel required: 10% as needed.

Knowledge & Skills

• Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, and industry standards.
• Knowledge of global labeling regulatory requirements, standards and processes.
• Demonstrated understanding of product development, and a comprehensive understanding of biology and pharmacology relevant to the therapeutic area.
• Analytical thinking and critical judgment.
• Ability to work and manage multiple assignments and timeline driven priorities; substantial project management skill.
• Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives.
• Demonstrated ability to lead teams.
• Interpersonal, organizational and negotiation skills.
• Strong technical writing skills.
• Strong collaboration, presentation, verbal and written communication, and leadership skills.
• Demonstrable conflict resolution and negotiation skills.
• Excellent project management and attention to detail.
• Experience working in a Regulatory Information Management system.
• Proficiency utilizing Microsoft Suite – Outlook, Word, Excel, PowerPoint.

What we expect of you

Basic Qualifications

• Doctorate degree and 2 years of related experience, OR
• Master’s degree and 4 years of related experience, OR
• Bachelor’s degree and 6 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

• Degree in life science or medicine
• Experience in Pharmaceutical Industry Regulatory Affairs and/or product labeling
• Expertise in product labeling within a Therapeutic Area
• Knowledge of FDA, EMA, and other international regulations for labeling
• Project Management Skills
• Understands the impact of emerging trends and their implications for Amgen
• Experience in managing individual and group projects of high to moderate complexity
• Experience working in a Veeva/Documentum-based document management system

What you can expect of us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is 132,972.30 USD – 179,903.70 USD. Actual salary will vary based on several factors including relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, that may include:

• A 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
• Flexible work models where possible

Application deadline

Amgen does not have an application deadline for this position; applications will be accepted until a sufficient number is received or a candidate is selected.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

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. Individuals with disabilities will be 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.