Instructional Designer

Position Summary

The Instructional Design Specialist evaluates, updates, redesigns, and develops FDA laboratory training courses for the Human Foods Program, Office of Laboratory Operations and Applied Science, Office of Regulatory Testing and Surveillance. The role applies current, evidence-based instructional design and adult learning standards to produce complete, instructionally sound course materials aligned with FDA requirements, Regulatory and Laboratory Training System standards, and the National Curriculum Standard for laboratory professionals.

Key Responsibilities

• Review existing laboratory course materials, including instructor guides, student manuals, presentations, guidance documents, laws, regulations, exercises, job aids, online courses, and related materials provided by FDA.

• Evaluate each course against current FDA regulations, policies, guidance, scientific standards, Regulatory and Laboratory Training System requirements, and the National Curriculum Standard for laboratory professionals.

• Conduct needs assessments with FDA subject-matter experts and project stakeholders to identify content gaps, outdated materials, instructional design deficiencies, and opportunities for electronic delivery.

• Prepare a written Course Evaluation, Status, and Recommendations Report and a Course Development Plan for each assigned course in accordance with FDA timelines and approval requirements.

• Use the ORTS Course Design Document and Instructor Guide templates to document the approved instructional approach and course content.

• Develop measurable learning objectives and organize lessons with clear introductions, objectives, content, practice activities, and summaries.

• Design active-learning, critical-thinking, hands-on, scenario-based, and performance-based activities appropriate for laboratory professionals and the course level.

• Develop complete course-material packages, including instructor guides, student guides or manuals, presentations with speaker notes, job aids, handouts, practice exercises, assessments, and course-evaluation instruments.

• Develop or support SCORM-compliant online prerequisite or pre-course modules compatible with the HHS learning management system when directed by FDA, and provide required source files and SCORM packages.

• Coordinate with FDA subject-matter experts, the COR, the designated ORTS Project Manager, accessibility staff, eLearning staff, media specialists, and applicable IT personnel throughout review, development, testing, and approval.

• Ensure presentations and visual aids follow FDA Visual Identity requirements and that materials are suitable for electronic delivery, free of copyright restrictions, and ready for Government ownership and use.

• Incorporate FDA-directed updates arising from policy, scientific, regulatory, judicial, RLTS, NCS, public-health, or emergency-response changes within assigned schedules.

Required Qualifications

• Demonstrated experience applying evidence-based instructional design methodologies and adult learning principles to professional, technical, scientific, or laboratory training.

• Experience conducting course evaluations, needs assessments, content-gap analyses, and instructional design reviews of existing training materials.

• Experience writing measurable learning objectives and developing active-learning, scenario-based, hands-on, or performance-based exercises and assessments.

• Experience developing instructor guides, student guides or manuals, presentations, job aids, handouts, assessments, and course-evaluation instruments.

• Ability to collaborate with scientific or technical subject-matter experts and translate complex material into clear, instructionally sound learning content.

• Ability to manage multiple course-development activities, Government review cycles, source files, and deliverables while meeting established timelines.

• Working knowledge of accessibility requirements for electronic learning materials and the ability to collaborate with Section 508 specialists during development and review.

• Strong writing, editing, communication, organization, and stakeholder-coordination skills.

Certifications and Preferred Qualifications

• Experience developing training for FDA, HHS, another public-health organization, or a regulated scientific or laboratory environment.

• Familiarity with Regulatory and Laboratory Training System standards and the National Curriculum Standard for laboratory professionals.

• Experience developing SCORM-compliant eLearning for a learning management system and coordinating delivery of source files, multimedia, graphics, animation, captions, and transcripts.

• Experience developing laboratory training that incorporates hands-on practice, analytical methods, scientific procedures, critical thinking, or performance-based evaluation.

• Experience applying federal visual-identity, accessibility, copyright, records, review, and Government-ownership requirements to training deliverables.