Senior Manager, Instructional Design and Labeling Operations

Senior Manager, Instructional Design and Labeling Operations 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.

• 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 navigate ambiguity, competing priorities, cross-functional dependencies, and escalation needs.

• Lead the Instructional Design and Labeling Operations function within Customer Experience and Design.

• Translate portfolio needs, Human Factors milestones, labeling deliverables, study timelines, submission needs, and business priorities into executable team plans.

• Establish mechanisms to monitor workload, workflow health, quality trends, cycle times, risks, rework drivers, and delivery commitments.

• Strengthen the operating model for Instructional Design and Labeling Operations, including role clarity, decision rights, intake, prioritization, escalation, metrics, and cross-functional handoffs.

• Ensure the team’s work supports broader Customer Experience objectives, including improved patient learning materials, usability, complaint reduction, and customer experience outcomes.

• Lead process improvement efforts across the IFU / NAF lifecycle, including NAF strategy, creation, revision, review cycles, Human Factors study support, source…