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Manager : CMR Knowledge and Technical Advancement
Location:
Plainsboro, NJ
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 and 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 stylemargin:bottom:11.0px::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 stylemargin:bottom:11.0px::A Bachelor's degree is required. An advanced degree is preferred:A minimum of eight (8) years ofprogressively responsible clinical development/trialexperience within a pharmaceutical, biotechnology, or CRO required.Training and Development, Operations and/or Learning and Developmentexperience 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
Posted:
May 8 on Tip Top Job
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Manager : CMR Knowledge and Technical Advancement is a Executive Manager Job located in Plainsboro NJ. Find other listings like Manager : CMR Knowledge and Technical Advancement by searching Oodle for Executive Manager Jobs.
Manager : CMR Knowledge and Technical Advancement is a Executive Manager Job located in Plainsboro NJ. Find other listings like Manager : CMR Knowledge and Technical Advancement by searching Oodle for Executive Manager Jobs.