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Specialist - Patient Safety And Gxp Instructional Design

3+ years
$81,010 – $145,820
10 Nov. 14, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Specialist – Patient Safety & GxP Instructional Design

Location: Plainsboro, United States
Category: Regulatory Affairs & Safety / Pharmacovigilance
Company: Novo Nordisk
Employment Type: Full-Time


About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most collaborative and diverse teams. CMR works across:

  • Healthcare provider engagement

  • FDA regulatory strategy

  • Medical education

  • Data and evidence generation for new product development

The team is united by a patient-centered mission—improving lives through innovation and scientific excellence.


Position Summary

The Specialist supports Novo Nordisk’s organizational learning strategy by:

  • Applying design thinking, adult learning theory, and modern instructional methods

  • Creating high-quality learning experiences

  • Leveraging advanced learning technologies

  • Enhancing employee performance and capability growth


Reporting & Key Relationships

Reports to:

  • Senior Director, GxP Compliance & Technical Operations
    or

  • GxP Compliance, Patient Safety, Vendor Oversight Director

Regular collaboration with:

  • Patient Safety

  • Quality

  • Vendor & Contract Management

  • IT

  • Finance

  • Customer Engagement Program suppliers

  • Other CMR functions


Essential Functions

1. Learning Design & Development

  • Design and develop impactful learning assets aligned with organizational and program goals

  • Create training content using strong instructional design fundamentals

  • Work with Subject Matter Experts (SMEs) for scientific, technical, and functional curriculum development

  • Innovate learning delivery using creative, modern design approaches

  • Drive continuous improvement in training methodologies


2. Program Design & Delivery

  • Support creation and rollout of in-person, virtual, and blended learning programs

  • Use instructional design best practices to develop engaging content

  • Apply design thinking to identify skill gaps, prototype solutions, and incorporate feedback

  • Ensure training aligns with adult learning principles


3. Agile Learning & Modern Principles

  • Integrate agile methods into Learning & Development (L&D) processes

  • Continuously iterate solutions based on data and learner feedback

  • Promote learner-centric approaches such as:

    • Microlearning

    • Social learning

    • Experiential learning activities


4. Instructional Design Application, Technology & Innovation

  • Use the ADDIE model to design curriculum and role-based learning programs

  • Write measurable SMART objectives connected with broader R&D goals

  • Ensure learning ROI and adherence to instructional design best practices

  • Incorporate strategies to reinforce knowledge application

  • Use advanced e-learning platforms and tools

  • Ensure technology solutions meet regulatory (GxP) and pharmaceutical training requirements

  • Collaborate with IT and vendors to pilot innovative technologies (e.g., VR, simulations)

  • Stay current with instructional design trends and e-learning tools


5. Stakeholder Engagement

  • Partner with CMR cross-functional teams to identify training needs

  • Build relationships with vendors and external thought leaders

  • Act as liaison between senior leadership and L&D for strategic learning decisions


6. Measurement & Continuous Improvement

  • Define and track key KPIs to evaluate training effectiveness

  • Use analytics, assessments, and feedback to refine programs

  • Foster a culture of continuous learning and improvement


Physical Requirements

  • Approximately 20% overnight travel


Qualifications

Education

  • Bachelor’s degree in:

    • Instructional Design

    • Instructional Technology

    • Education

    • Communications

    • Or related field

  • Master’s degree preferred

  • ATD certification is a plus

Experience

  • 3+ years in pharmaceutical training, clinical research, or regulatory affairs

  • Strong proficiency in adult learning theory and instructional methodologies

  • Experience delivering and facilitating instructor-led sessions (scientific & technical content)

  • Hands-on experience with learning tools such as:

    • Articulate Storyline

    • Articulate Rise

    • Microlearning platforms

    • Video-based learning tools

Skills

  • Strong instructional design and content creation skills

  • Project management capability for multiple concurrent projects

  • Experience with LMS platforms and e-learning technologies

  • Adaptive, innovative mindset with awareness of industry trends


Compensation & Benefits

Base Salary Range

$81,010 – $145,820
(based on experience and other factors)

Additional Compensation

  • Company performance bonus

  • Eligibility for long-term incentive compensation

  • Company vehicle (depending on position level)

Benefits

  • Medical, dental, and vision insurance

  • Life and disability coverage

  • 401(k) savings plan

  • Flexible spending accounts

  • Employee assistance program

  • Tuition reimbursement

  • Voluntary benefits (legal, critical illness, identity theft, pet insurance, auto/home insurance)

  • Sick time, flexible vacation policy, and parental leave


Diversity, Inclusion & Accessibility

Novo Nordisk is an equal opportunity employer. All hiring decisions are made without discrimination based on:

  • Race

  • Ethnicity

  • Religion

  • Gender or gender identity

  • Sexual orientation

  • Disability

  • Veteran status

  • National origin

  • Any legally protected category

Applicants needing accommodations can contact:
📞 1-855-411-5290
(Accommodation requests only)