Senior Manager, Instructional Design and Labeling Operations
Listed on 2026-09-18
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Management
Regulatory Compliance Specialist, Operations Management
Senior Manager, Instructional Design And Labeling Operations
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.
What You Will Do
Let's do this. Let's change the world. The Senior Manager, Instructional Design and Labeling Operations will lead the Instructional Design team within Customer Experience and Design, supporting the development, lifecycle management, review, and operational execution of Instructions for Use (IFUs), Native Artwork Files (NAFs), and related instructional artwork deliverables for combination products and other regulated medical products.
This role is first and foremost a people leadership and operational excellence role. The Senior Manager will lead a mixed team of Amgen employees and external workers, build team capability, strengthen career development, manage capacity and priorities, and mature the Instructional Design and Labeling Operations function. The role will also own the process governance, implementation, adherence, and continuous improvement of SOP-437076, ensuring that Instructional Design workflows are clear, scalable, compliant, and effectively integrated into cross-functional product development and submission activities.
The successful candidate does not need to be a formal instructional designer. However, they must bring strong people leadership, process ownership, stakeholder management, and regulated medical product experience, with the ability to lead teams working across labeling, artwork, Human Factors study support, source text alignment, documentation, review cycles, vendor coordination, and Health Authority submission readiness.
This leader will partner closely with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, Systems Engineering, Final Product Teams, Quality, vendors, and other cross-functional stakeholders to ensure deliverables are completed with quality, traceability, usability, compliance, and business impact.
Key Responsibilities:
People Leadership and Team Development
- Lead, coach, and develop a team of Instructional Design Engineers
- Serve as a career development champion by clarifying role expectations, supporting development plans, creating growth opportunities, and helping team members build differentiated career paths.
- Build a high-performing team culture grounded in accountability, collaboration, learning, quality, operational discipline, and customer focus.
- Manage team priorities, workload, capacity, onboarding, performance, development, and resource allocation.
- Provide effective oversight of external workers and/or contractors, including onboarding, work assignment, deliverable expectations, execution quality, and integration into team workflows.
- Help the team…
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