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Amgen
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. 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.
Associate Director - Global Labeling Compliance AIN
Let’s do this. Let’s change the world. In this vital role you will lead and oversees the implementation of labeling strategies, processes and systems. This role involves collaborating with cross-functional teams, including Regulatory Affairs, Quality, Operations and Supply Chain, to ensure global labeling compliance, streamline operations, and uphold high-quality standards. The Associate Director will act as a senior point of contact for global, regional and local teams, advising on strategic decisions and maintaining inspection readiness and will be the main point of contact for global labeling related compliance and audits. Additionally, this individual will mentor team members, optimize vendor relationships, and drive continuous improvement within labeling processes and systems.
Strategic Leadership and Process & System Optimization:
Lead the strategic development and execution of labeling processes, systems and compliance initiatives across regions.
Ensure alignment of labeling operations with global regulatory requirements, maintaining high standards and facilitating readiness for inspections.
Drive continuous process improvement, implementing standard methodologies and refining workflows to enhance labeling efficiency and compliance.
Partner with Regional Regulatory Affairs, Local Amgen Affiliates, and Operations teams to plan, implement, and monitor labeling changes, providing expert guidance to ensure regulatory compliance.
Act as a senior advisor on complex labeling issues, coordinating closely with key collaborators to address labeling requirements across global markets.
Be responsible for relationships with labeling vendors, managing performance to meet established Service Level Agreements (SLAs) and addressing critical issues as needed.
Lead project management efforts for multi-regional labeling changes, coordinating cross-functional resources to meet timelines and regulatory requirements.
Manage and monitor translation and artwork vendors, ensuring that project achievements and quality standards are consistently achieved.
Lead operational activities to support US, EU, and other regional labeling processes, including the management of templates, readability, linguistic reviews, and regulatory formatting.
Provide oversight for document management, including labeling templates, Standard Operating Procedures (SOPs), and training materials.
Team Development and Mentorship:
Mentor and train team members and other staff on end-to-end labeling processes, fostering professional growth and knowledge sharing within the team.
Develop training programs to elevate the understanding and application of labeling standards among junior team members and global regulatory staff.
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Doctorate degree and 3 years of Pharmaceutical, Regulatory, or Quality Management experience OR
Master’s degree and 10 to 14 years of Pharmaceutical, Regulatory, or Quality Management experience OR
Bachelor’s degree and 14 to 16 years of Pharmaceutical, Regulatory, or Quality Management experience OR
Diploma and 18 to 20 years of Pharmaceutical, Regulatory, or Quality Management experience
Preferred Qualifications:
Experience with Labeling Management Systems preferably Veeva Vault.
Expertise in global regulatory labeling requirements, especially for pharmaceuticals, with experience in end-to-end labeling.
Strong project management and vendor management capabilities.
Proficient in document management tools, with an analytical attitude for anticipating and resolving issues.
Excellent communication and negotiation skills, with a proven ability to foster relationships across diverse teams.
Demonstrated experience in continuous improvement practices and cross-functional leadership.
As 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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Objects in your future are closer than they appear. Join us.
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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