Senior Patient Safety and GxP Training Matrix and Curriculum Manager

Senior Patient Safety And GxP Training Matrix And Curriculum Manager

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference?

We are seeking a detail-oriented and passionate Training Manager to join our Clinical, Medical, Regulatory (CMR) group at Novo Nordisk. This role is essential in ensuring our CMR professionals are equipped with the knowledge, skills, and regulatory expertise needed to advance life-changing treatments for patients with diabetes and other serious chronic diseases. You will coordinate and deliver comprehensive training programs that support clinical excellence, regulatory compliance, and medical affairs expertise across our global CMR organization. The ideal candidate will have a strong understanding of pharmaceutical regulations, clinical research processes, and adult learning principles, combined with exceptional organizational skills and a commitment to maintaining the highest standards of training delivery in a highly regulated environment.

This job reports to the Senior Director of the GxP Compliance & Technical Operations or the GxP Compliance, Patient Safety, Vendor Oversight Director. This job will interact with Patient Safety, Quality, Vendor and Contract Management, IT, Finance, Contract / Supplier of Customer Engagement Programs, and other CMR Functional areas.

Essential Functions

• Create job-specific training curricula for different roles within clinical operations, medical affairs, and regulatory affairs
• Maintain training assignments on clinical research documentation, regulatory requirements, Good Clinical Practice (GCP), and medical affairs procedures
• Develop training needs assessments to identify knowledge gaps and learning requirements across CMR functions
• Ensure training materials are compliant with company standards and regulatory requirements
• Regulatory & Compliance Training
• Develop and deliver training on regulatory guidelines including FDA, EMA, ICH-GCP, and other global regulatory requirements
• Coordinate mandatory compliance training for clinical research staff, including GCP certification and recertification programs
• Support live offerings of SOP training, including logistics, venue booking, materials preparation, technology setup, and participant registration
• Coordinate with subject matter experts (SMEs) to develop and deliver specialized training content for clinical trials, regulatory submissions, and medical communications
• Ensure training programs meet regulatory audit requirements and maintain comprehensive training documentation
• Support preparation for regulatory inspections by ensuring all CMR staff have current and compliant training records
• Stay current with evolving regulatory requirements and update training materials accordingly
• Learning Management & Documentation
• Maintain the Learning Management System (LMS) for CMR training programs, ensuring accurate records of participation and completion
• Generate training reports and analytics to track completion rates, effectiveness, and compliance metrics
• Manage training documentation including attendance records, certificates, and qualification matrices
• Develop and maintain standard operating procedures (SOPs) for training processes and documentation
• Content Development
• Collaborate with CMR subject matter experts to create engaging training materials, presentations, and e-learning modules
• Update existing training content to reflect current regulations, company procedures, and industry best practices
• Quality Assurance & Continuous Improvement
• Monitor training effectiveness through participant feedback, assessments, and performance metrics
• Conduct regular reviews of training programs to ensure relevance, accuracy, and regulatory compliance
• Implement quality improvement initiatives based on feedback and training analytics
• Support internal and external training audits by providing documentation and process information
• Collaborate with Quality Assurance teams to ensure training programs support overall quality management systems

Physical Requirements

Approximately 20% overnight travel.

Qualifications

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.

The base compensation range for this position is $116,810 to $216,100. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Novo Nordisk offers long-term incentive compensation and / or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto / home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.