Senior Patient Safety and GxP Training Matrix and Curriculum Manager

Novo Nordisk

Plainsboro, NJ

JOB DETAILS
SALARY
$116,810–$216,100 Per Year
LOCATION
Plainsboro, NJ
POSTED
30+ days ago


About the Department





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?








The Position


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.





Relationship


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


+ Key Area #1 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





+ Key Area #2 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



+ Key Area #3 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





+ Key Area # 4 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



+ Bachelor's degree in Life Sciences, Healthcare Administration, Education, or related field


+ 7+ years of experience in pharmaceutical training, clinical research, or regulatory affairs


+ Strong knowledge of clinical research processes, Good Clinical Practice (GCP), and pharmaceutical regulations


+ Experience with Learning Management Systems (LMS) and training administration


+ Excellent presentation and facilitation skills with ability to engage diverse audiences


+ Strong project management and organizational skills with attention to detail


+ Proficiency in Microsoft Office Suite, particularly PowerPoint, Excel, and database management


+ Understanding of adult learning principles and instructional design concepts









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.





We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.





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.

About the Company

N

Novo Nordisk

Working at Novo Nordisk

 

Life-changing careers

Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.

Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.

 

We are inspired by life

We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.

We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.

 

Together we drive change

Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.

We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.

That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.

 

Together, we are life-changing

Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.

 

Your development starts here

We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.

It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile. 

With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.

In the video above, meet  Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.

 

Who we are

We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, Denmark.

Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. We do so by pioneering  scientific breakthroughs, expanding  access to our medicines , and working to prevent and ultimately cure diabetes.

With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.

COMPANY SIZE
2,500 to 4,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1923
WEBSITE
https://www.novonordisk.com/