Senior Manager, Instructional Design and Labeling Operations

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Manager Instructional Design and Labeling Operations

What you will do

Lets do this. Lets 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 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

We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications

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 OR

• 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 OR

• 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 OR

• 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 OR

• 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

And

In addition to meeting at least one of the above requirements you must have a minimum of 2 years 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

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 well support your journey every step of the way.

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 based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

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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