Join Amgen’s Mission of Serving PatientsAt 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. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.What you will doThe purpose of the Labeling Strategy and Compliance (LSC) group is to 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 decision 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 Strategist 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 and provides feedback 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 provides tangible solutions to labeling issues.
Supervises direct reports and supports their career development, if applicable.
Represents labeling on product-specific global regulatory teams.
Amount of travel required 10% as needed,
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 is required, 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, with demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
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, interpersonal, 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.
Basic Qualification
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 usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.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.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 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, including remote and hybrid work arrangements, where possible
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn 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 deadlineAmgen 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.