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)
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