Labeling Strategist, Manager

Amgen • Thousand Oaks, CA

3d

About The Position

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. 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. Labeling Strategist, Manager 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. As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Labeling Strategist, Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre & post marketed products over the products life cycle. The Labeling Strategist, Manager will support the development of the Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s). Live What you will do Let’s do this. Let’s change the world. In this vital role you will [top-line statement connecting primary position responsibility to employer brand].

Requirements

• 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

Nice To Haves

• Degree in pharmaceuticals, natural science or medicine
• Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
• Knowledge of labeling within a Therapeutic Area
• Knowledge of FDA, or EMA, or other international regulations for labeling
• Collaboration, presentation, communication, interpersonal, and leadership skills
• Experience working in a Documentum-based document management system

Responsibilities

• Authors (user friendly, international language, consistent across products) and maintains core labeling documents including cCDS, cPIL, and cIFU in addition to dCDS, dIFU, USPI, and medguide
• Chairs/leads the Labeling Working Group, and presents to Executive Labeling Board
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends
• Advises internal and/or external specialists on the creation of high quality documents supporting changes to the core labeling documents and runs 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.
• Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
• Represents labeling on product-specific global regulatory teams

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED