Associate Director - CMR Knowledge & Technical Advancement

About the Department                                                                                                                                               

The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-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

Manage a team ensuring consistency and harmonization of the implementation of the CMR training strategy. Serve as the CMR Training representative; Liaise with global and HQ counterparts to promote quality and consistency across regions. Ensure compliance with SOPs, KPIs, internal processes; Track and measure specific CMR technical metrics. Work to accelerate innovation across CMR functions within the role-based training processes (i.e. automation, technology, process optimization).

 

Relationships

Reports to Director or above within CMR Training & Knowledge Management. Collaborates with global and CMR leaders and stakeholders to develop, design, and evolve a comprehensive onboarding and training strategy for CMR employees. Develops and maintains excellent working relationship with functional leaders within CMR to maximize consistency, quality, and customer service.

 

Essential Functions

• Manage a team ensuring consistency and harmonization of the implementation of the CMR training strategy
• Ensuring CMR employees receive training on regulatory compliance, quality standards, GxP requirements and industry-specific guidelines as they pertain to their roles
• Identifying and addressing specific technical competency/skill gaps across CMR, developing training strategies to close the knowledge gaps (for example: New TA knowledge, New Trial/Protocol etc.)
• Collaborate with Subject Matter Experts to ensure that training programs/initiatives align with the latest industry trends, regulations, and best practices
• Facilitating the transfer of critical knowledge and expertise from experienced personnel to new employees, ensuring the preservation and dissemination of institutional knowledge
• Serve as the CMR Training representative; Liaise with global and HQ counterparts to promote quality and consistency across regions
• Ensure compliance with SOPs, KPIs, internal processes; Track and measure specific CMR technical metrics
• Work to accelerate innovation across CMR functions within the role-based training processes (i.e. automation, technology, process optimization)

 

Physical Requirements

10-20% overnight travel required; May be required to work company holidays and weekends.

 

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

• A Bachelor’s degree required, advanced degree preferred
• A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, Training & Development or Operations experience preferred
• Three (3) or more years of Managerial experience required
• Knowledge and understanding of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required
• Demonstrates technical expertise within Clinical Development, Medical Affairs, and Regulatory Affairs (CMR), staying up-to-date of new approaches & practices and building knowledge of emerging trends and advances within area
• Partners closely with CMR LT and P&O organization to understand existing and future training and knowledge management needs
• Proven track record of developing training and application in a technical business environment
• Excel