- 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
Physical Requirements
10-20% overnight travel required; May be required to work company holidays and weekends.
Qualifications- A Bachelor's degree is required. An advanced degree is preferred
- A minimum of eight (8) years of progressively responsible clinical development/trial experience within a pharmaceutical, biotechnology, or CRO required. Training & Development, Operations and/or Learning and Development experience preferred
- A minimum of 2 years prior training experience preferred
- Demonstrated competency in coaching and training of clinical research staff
- Advanced knowledge of Good Clinical Practice (GCP), ICH Guidelines, federal and local regulations, and clinical research process
- Strong solution-oriented customer focus
- Good communication, collaboration and influencing skills
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
- A Bachelor's degree is required. An advanced degree is preferred
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Manager - CMR Knowledge & Technical Advancement - Plainsboro, United States - Novo Nordisk
Description
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
Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate with functional CMR stakeholders to develop, deploy, and archive functional and role-based training material. Identify training needs within CMR function; Assess training gaps and identify role-specific learning requirements (SOPs, internal processes, etc.) in partnership with CMR Subject Matter Experts. Collaborate with internal and external stakeholders, both locally and globally, to seek alignment and share resources across multiple groups.
Relationships
Reports to Associate Director or above within CMR Training & Knowledge Management. Collaborates with global and CMR leaders and stakeholders to develop comprehensive role-based curricula for CMR employees. Develops and maintains excellent working relationship with functional leaders within CMR to maximize consistency, quality, and customer service.
Essential Functions
