Novo Nordisk
Senior Director - CMR Knowledge and Technical Advancement
Novo Nordisk, Plainsboro, New Jersey, United States
Senior Director - CMR Knowledge and Technical Advancement
Location:
Plainsboro, United States Job category:
Clinical Development 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 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:
The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an advisor to North America Operations (NAO) CMR organization on all aspects of new and existing CMR employee onboarding, cultural engagement, technical/role-specific training, and GxP/Regulatory compliance across CMR functions. The position will serve as an integral member of the CMR Strategic Operations (SO) Leadership Team and will be responsible for leading the strategy, development, and effective execution of CMR foundational and role-specific/technical training (e.g. clinical trial-related, GxP, Compliance, etc.) across the US and Canada as well as supporting the CMR/non-CMR activities in Mexico City GBS and East Coast Hub. They will develop and manage cross-CMR training and education plans to ensure strong foundational knowledge across all CMR functions to maximize operational efficiency between functional areas (e.g., in new Therapeutic Areas). They are responsible for ensuring alignment to global and HR training and onboarding plans. They will also be responsible for the housing and maintenance of foundational materials required for the CMRLT and CMR organization to ensure the team has access to critical knowledge required for cross CMR engagement. Relationships:
Reports to the Head of CMR Strategic Operations. Supervises a team of CMR Learning Support Partners, technical trainers, and knowledge management staff. Closely partners with line leaders, Global Development key stakeholders, and the HR organization in understanding, designing, and executing prioritized key training initiatives/programs. External relationships include working with East Coast Hub, GBS Units (Bangalore and MXCO), P&O Functions as well as various external vendors and adult learning KOLs as required. May also provide input or implement global Development and R&D training initiatives. Essential Functions: Responsible for leading the strategy, development, and effective execution of CMR role-specific/technical training (e.g. clinical trial-related, patient safety, therapeutic area leads, MSLs, etc.) across the US and Canada. Responsible for leading the strategy, development, and effective execution of Functional new hire onboarding to CMR and Cultural Engagement & Immersion for CMR/non-CMR GBS units as well as East Coast Hub (ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives. Lead a team of Role-Specific Training Support Partners to ensure training plans are developed & deployed at the CMR functional level, GxP compliant execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs. Develop and implement knowledge management technology strategies to identify, track, store, and disseminate critical CMR training documentation. Ensure training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials across CMR. Accountable for budget records and prepares documents required for the budget review processes. Develop requests for proposals; evaluate and provide input into vendor selection based on costs, qualifications, and other pertinent factors based on the project; and coordinate legal review of finalized contracts; manage vendors to ensure the seamless integration of high-quality vendor products with the learning curriculum. Collaborate exceptionally well with key individuals and leaders throughout the organization to ensure in-depth understanding of market and individual/local needs and that resources and systems are aligned with market/customer needs. Demonstrate technical expertise within functional responsibility area, staying up-to-date of new approaches & practices and building knowledge of emerging trends and advances within the area. Build and maintain trusting, collaborative relationships and alliances with others inside and outside of the organization, which helps accomplish key business objectives. Physical Requirements: 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 related field preferred. 12+ years of progressive Training & Knowledge Management in a Pharmaceutical environment required. Five (5) or more years of Managerial experience required. Demonstrated ability to manage people, to effectively coach scientific/clinical persons at all skill and knowledge levels, to provide constructive feedback, to plan both strategy and implementation, and work effectively cross-functionally are essential. Knowledge and understanding of GxP training compliance, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Proven track record in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs, Patient Safety required. A thorough understanding and proven track record in the following areas: training needs assessment; training material/content build; development and implementation of job training matrices and curricula; technical training program evaluation, implementation, and facilitation. Knowledge and experience in cultural engagement and new employee onboarding experience. Knowledge of technical, digital, and software systems for training and knowledge management systems required. 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 the 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. Join us and drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases.
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Location:
Plainsboro, United States Job category:
Clinical Development 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 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:
The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an advisor to North America Operations (NAO) CMR organization on all aspects of new and existing CMR employee onboarding, cultural engagement, technical/role-specific training, and GxP/Regulatory compliance across CMR functions. The position will serve as an integral member of the CMR Strategic Operations (SO) Leadership Team and will be responsible for leading the strategy, development, and effective execution of CMR foundational and role-specific/technical training (e.g. clinical trial-related, GxP, Compliance, etc.) across the US and Canada as well as supporting the CMR/non-CMR activities in Mexico City GBS and East Coast Hub. They will develop and manage cross-CMR training and education plans to ensure strong foundational knowledge across all CMR functions to maximize operational efficiency between functional areas (e.g., in new Therapeutic Areas). They are responsible for ensuring alignment to global and HR training and onboarding plans. They will also be responsible for the housing and maintenance of foundational materials required for the CMRLT and CMR organization to ensure the team has access to critical knowledge required for cross CMR engagement. Relationships:
Reports to the Head of CMR Strategic Operations. Supervises a team of CMR Learning Support Partners, technical trainers, and knowledge management staff. Closely partners with line leaders, Global Development key stakeholders, and the HR organization in understanding, designing, and executing prioritized key training initiatives/programs. External relationships include working with East Coast Hub, GBS Units (Bangalore and MXCO), P&O Functions as well as various external vendors and adult learning KOLs as required. May also provide input or implement global Development and R&D training initiatives. Essential Functions: Responsible for leading the strategy, development, and effective execution of CMR role-specific/technical training (e.g. clinical trial-related, patient safety, therapeutic area leads, MSLs, etc.) across the US and Canada. Responsible for leading the strategy, development, and effective execution of Functional new hire onboarding to CMR and Cultural Engagement & Immersion for CMR/non-CMR GBS units as well as East Coast Hub (ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives. Lead a team of Role-Specific Training Support Partners to ensure training plans are developed & deployed at the CMR functional level, GxP compliant execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs. Develop and implement knowledge management technology strategies to identify, track, store, and disseminate critical CMR training documentation. Ensure training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials across CMR. Accountable for budget records and prepares documents required for the budget review processes. Develop requests for proposals; evaluate and provide input into vendor selection based on costs, qualifications, and other pertinent factors based on the project; and coordinate legal review of finalized contracts; manage vendors to ensure the seamless integration of high-quality vendor products with the learning curriculum. Collaborate exceptionally well with key individuals and leaders throughout the organization to ensure in-depth understanding of market and individual/local needs and that resources and systems are aligned with market/customer needs. Demonstrate technical expertise within functional responsibility area, staying up-to-date of new approaches & practices and building knowledge of emerging trends and advances within the area. Build and maintain trusting, collaborative relationships and alliances with others inside and outside of the organization, which helps accomplish key business objectives. Physical Requirements: 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 related field preferred. 12+ years of progressive Training & Knowledge Management in a Pharmaceutical environment required. Five (5) or more years of Managerial experience required. Demonstrated ability to manage people, to effectively coach scientific/clinical persons at all skill and knowledge levels, to provide constructive feedback, to plan both strategy and implementation, and work effectively cross-functionally are essential. Knowledge and understanding of GxP training compliance, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Proven track record in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs, Patient Safety required. A thorough understanding and proven track record in the following areas: training needs assessment; training material/content build; development and implementation of job training matrices and curricula; technical training program evaluation, implementation, and facilitation. Knowledge and experience in cultural engagement and new employee onboarding experience. Knowledge of technical, digital, and software systems for training and knowledge management systems required. 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 the 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. Join us and drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases.
#J-18808-Ljbffr