Senior Manager, Instructional Design and Labeling Operations

Key Responsibilities

• 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.

Functional Leadership and Operating Model

• 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.

SOP Ownership and Process Improvement

• Lead process improvement efforts across the IFU / NAF lifecycle, including NAF strategy, creation, revision, review cycles, Human Factors study support, source text alignment, submission support, vendor coordination, and launch readiness activities.
• Develop, maintain, and improve supporting tools such as templates, checklists, standards, process maps, training materials, metrics, and review expectations.
• Identify and resolve process gaps, handoff inefficiencies, documentation risks, role clarity issues, recurring workflow pain points, and compliance vulnerabilities.
• Champion scalable and compliant ways of working that improve predictability, audit readiness, quality, speed of execution, and team sustainability.

Instructional Design, Labeling Operations, and Regulated Artwork Oversight

• Provide leadership oversight for development and revision of IFUs, instructional artwork, illustrations, NAFs, study stimuli, and related deliverables used to support development activities, Human Factors studies, Health Authority interactions, and product commercialization.
• Ensure Instructional Design deliverables are developed and maintained with appropriate attention to user needs, usability principles, labeling requirements, regulatory expectations, documentation traceability, and quality standards.
• Oversee activities related to NAF strategy, artwork creation, review cycles, source text alignment, print readiness, study stimuli preparation, vendor coordination, and submission readiness.
• Ensure appropriate quality checks, review discipline, documentation, and inspection practices are in place before deliverables progress to formal review, study use, or submission.
• Support issue resolution and decision-making when design, usability, labeling, regulatory, packaging, artwork, quality, or operational considerations conflict.

Cross-Functional Collaboration and Vendor Management

• Build strong partnerships with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, Systems Engineering, Quality, Final Product Teams, vendors, and other partners.
• Represent Instructional Design and Labeling Operations in portfolio, program, governance, and process discussions where team commitments, risks, vendor performance, or functional strategy are impacted.
• Communicate priorities, risks, decisions, and tradeoffs clearly to senior leaders and cross-functional stakeholders.
• Influence across matrix teams to drive alignment, remove barriers, and maintain momentum.
• Manage vendor and contractor relationships to support execution, capacity, quality, specialized capability, print readiness, study support, and process reliability.
• Ensure vendors and external partners understand applicable expectations, timelines, deliverable standards, documentation needs, and escalation pathways.

Quality, Compliance and Inspection Readiness

• Ensure Instructional Design and Labeling Operations activities are performed and documented in accordance with applicable procedures, standards, and regulatory expectations.
• Promote strong documentation practices, including traceability of inputs, decisions, reviews, revisions, approvals, study support activities, and submission-related deliverables.
• Support audit readiness, inspection readiness, and response to Health Authority questions or feedback related to Instructional Design and labeling operations deliverables.
• Drive a culture of quality ownership, right-first-time execution, and continuous learning from errors, rework, study outcomes, stakeholder feedback, and process metrics.