Senior Manager, Instructional Design and Labeling Operations

Senior Manager, Instructional Design and Labeling Operations The Senior Manager, Instructional Design and Labeling Operations leads 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 people‑leadership and operational excellence role includes managing a mixed team of Amgen employees and external workers, building team capability, strengthening career development, managing capacity and priorities, and maturing the Instructional Design and Labeling Operations function. What You Will Do 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 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 teams 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. What We Expect Of You Basic Qualifications Doctorate degree and 2 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience. Masters degree and 6 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience. Bachelors degree and 8 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience. Associates degree and 10 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience. High school diploma / GED and 12 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience. In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred Qualifications Demonstrated people leadership experience, including coaching, performance management, career development, workload management, and building high‑performing teams. Experience leading FTEs, external workers, contractors, vendors, or matrixed contributors in a regulated or quality‑sensitive environment. Experience in regulated medical product labeling, artwork, packaging, Human Factors, medical device, pharmaceutical, biotechnology, combination product, quality, or design operations. Combination product experience preferred; broader regulated medical space labeling or artwork experience may be suitable. Experience improving processes, implementing SOPs, developing templates/checklists, defining role clarity, and scaling functional operations. Experience owning or governing controlled procedures, including implementation, adherence, training, inspection readiness, and continuous improvement. Knowledge of IFUs, instructional materials, labeling/artwork development, Human Factors study materials, Health Authority submission support, or regulated document workflows. Experience with document management systems, review workflows, source text/artwork alignment, traceability, and audit‑ready documentation. Vendor management experience, including defining expectations, managing deliverables, monitoring performance, and resolving quality or timeline issues. Strong cross‑functional leadership and influencing skills with the ability to align stakeholders across technical, regulatory, quality, operational, and design perspectives. Ability to manage multiple priorities, identify risks, escalate appropriately, and drive decisions in a matrixed environment. Strong written, verbal, facilitation, and executive communication skills. Demonstrated ability to translate customer, patient, user, and business needs into practical operational improvements. Lean, Six Sigma, process excellence, change management, or operational excellence experience preferred. What You Can Expect Of Us The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, including Health and Welfare Plans for Staff and Eligible Dependents, Financial Plans to help save for retirement or other goals, Work/life Balance initiatives, and Career Development Opportunities. The benefits package includes: 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. 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. #J-18808-Ljbffr BioSpace