Sr Associate - Instructional Design/Labeling Specialist
The Instructional Designer/ Labeling leads design and development of labeling content, form factors, information architecture, typography, illustrations, to promote safe and effective use of Amgen products for users around the world. Develops labeling based upon current industry standards, best practices, study results. Coordinates labeling reviews and approvals throughout Amgen, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates. The role involves knowledge of specific labeling regulations (e.g., EMA or FDA labeling rules) and review of local labeling to assure compliance with corporate labeling. This role will apply Design Thinking to drive transformational innovation and ensure "the right product the first time" to support Amgen's mission to serve patients.
- Design, iterate and develop information for safety including: product labeling, instructions for use corresponding illustrations, quick reference guides, USPI, MedGuide, and clinical instructions.
- Manages and contributes to the development of final artwork, IFU, QRGs, updates to the labeling procedures, training materials, clinical instructional materials.
- Collaborate with Labeling Specialists and labeling change request initiators to understand requirements in order to help solve problems with design solutions in an innovative, cost effective and timely manner.
- Participates in planning, organizing, and executing visual information production projects for the human factors engineering team.
- Works with customer experience, packaging engineering, and branding, HF, and artwork center to create layout templates for use in HF studies.
- Develop innovative approaches for simplifying and explaining complex information.
- Verify labeling against input documents and labeling artwork that convey effective visual design of typography, graphics and space to maximize visual impact and to emphasize safe and effective use of the combination product
- Creates instructional templates and illustrations that can be leveraged across Amgen.
- Evaluates content to establish and maintain standardized labeling across Amgen product portfolios.
- Maintain compliance with relevant standards and regulations in performing the duties associated with this role in accordance with standards/procedures, training curriculums, continuous improvement initiatives, and routing and approval of assigned labeling deliverables Change control and documentation processes.
- Provide technical expertise and an operational perspective to moderately complex labeling design activities by identifying, defining and implementing process improvement solutions.
Creates, assesses, and develops drug agnostic, user-centric content for use in instructional materials across platforms.
- Leads LCM instructional material improvement projects.
- Master's Degree
- Bachelor's degree and 2 years of Labeling Design, Instructional Design, Graphic Design, Visual Design, User Experience Design (UxD), User Interface (UI) Design, Content Development or related experience in medical device/combination products or healthcare
- Associates degree and 6 years of Labeling Design, Instructional Design, Graphic Design, Visual Design, User Experience Design (UxD), User Interface (UI) Design, Content Development or related experience in medical device/combination products or healthcare
- High school diploma/GED and 8 years of Labeling Design, Instructional Design, Graphic Design, Visual Design, User Experience Design (UxD), User Interface (UI) Design, Content Development or related experience in medical device/combination products orhealthcare
- 8 years of creating, designing, and developing labeling, instructions for use (IFU) for medical devices or combination products
- Knowledge of relevant human factors regulations, standards and guidance for medical devices and pharmaceutical packaging
- Experience conceptualizing and/or designing instructional documents, labeling, and/or packaging of medical devices or combination products
- Excellence in visual design to promote quick and easy identification of essential information, proper flow of information, critical information to perform tasks while framing expectations to facilitate use, promote understanding and lessen the cognitive burden on users
- Experience within brand design and print production is preferred
- Able to translate complex product information into concise, compliant, easy-to-follow instructions for use
- Experience with usability engineering in the medical, pharmaceutical, and/or healthcare industry
- Skills in Microsoft Word, Excel, PowerPoint, and Outlook required
- Strong graphic design, page layout, illustrations, typography, and instructional design skills
- Advanced proficiency with Adobe Creative Suite (InDesign, Illustrator, Photoshop) and preparing artwork for printing
- Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines
- Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience
- Subject matter expert of principles and industry application of Medical Device and healthcare regulations including: FDA's Human Factors Guidance, Labeling for home use, 14971, 62366. HE 75, EU Annex 1, 21 CFR parts 4, 820, 210 and 211, MHRA HF Guidance, FDAs Quality System Regulation (QSR), ISO 13485, EN 60601, Council Directive 93/42/EEC, Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, Design Considerations for Devices Intended for Home Use, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, Draft Guidance for Industry List of Highest Priority Devices for Human Factors Review, Applying Human Factors and Usability Engineering to Medical Devices, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, General Device Labeling - 21 CFR Part 801, Use of Symbols - 21 CFR Part 801.15