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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 strategic leader for the role of GxP Patient Safety, Compliance & Vendor Oversight within our Clinical, Medical & Regulatory (CMR) organization. This position combines the critical functions of patient safety training, compliance curriculum management, and vendor oversight to ensure adherence to regulatory standards while enhancing our operational capabilities through strategic vendor partnerships.

Relationship

This job reports to the Senior Director of the GxP Compliance & Technical Operations. 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. This job will lead a team of Patient Safety training and vendor training oversight managers working with internal and external stakeholders.

Essential Functions

+ Partner with CMR leadership to integrate compliance considerations into research planning and execution across all phases of drug development

+ Develop and maintain Patient Safety onboarding and on-the-job training for pharmacovigilance employees, while also delivering safety training for internal and external stakeholders

+ Design and implement comprehensive compliance training programs tailored to CMR personnel, ensuring effective learning and adherence to GxP standards

+ Maintain learning management systems and track training completion rates to ensure compliance with safety and regulatory requirements

+ Lead the development and delivery of training on case processing, safety reporting, and relevant regulatory guidelines (FDA, EMA, ICH)

+ Conduct regular assessments of training needs and knowledge gaps to inform ongoing training strategy

+ Key Area #1

+ Learning Strategy & Development

+ Develop a holistic learning strategy focused on enhancing employee knowledge and compliance within the CMR organization

+ Design and develop deployment and delivery methods to address learning needs

+ Align with key business objectives to ensure fit for purpose learning

+ Evaluate training curricula and make adjustments based on feedback, compliance audits, and evolving regulatory standards

+ Key Area #2

+ Lead the strategic management of key vendors supporting CMR business processes and patient safety functions

+ Develop vendor scorecards, performance metrics, and compliance tracking to ensure optimal vendor performance and adherence to contractual obligations

+ Negotiate contracts, manage risks, and build strategic partnerships with vendors to drive innovation and enhance service delivery

+ Oversee vendor onboarding, training, and integration processes, ensuring smooth operational alignment and compliance with GxP requirements

+ Key Area #3

+ Review and approve vendor-related Standard Operating Procedures (SOPs) and ensure documentation meets regulatory and internal standards

+ Maintain up-to-date knowledge of industry regulations and guidelines to ensure compliance with adverse event processing and reporting

Physical Requirements

Approximately 20% overnight travel.

Development of People

Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

+ BA/BS degree required; advanced degree in a related field is preferred

+ 10+ years of experience in pharmaceutical, regulatory affairs, or compliance roles, with a strong background in patient safety and vendor management

+ Proven track record in curriculum development, compliance training, and vendor relationship management

+ Strong understanding of GxP training compliance, FDA regulations, ICH Guidelines, and quality management systems

+ Exceptional project management and communication skills

+ Excellent presentation, communication, negotiation, and relationship-building skills

+ Proficiency in learning management systems and data analysis platforms

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 $148,290 to $259,510. 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.