Senior Director - CMR Knowledge and Technical Advancement - Novo Nordisk

Plainsboro, NJ

About the Job

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 on-boarding, cultural engagement, technical/role-specific training and GxP/Regulatory compliance across CMR functions. Position will serve as an integral member of the CMR Strategic Operations (SO) Leadership Team and will be responsible for leading the strategy, development, 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 support 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 to ensure 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 CMR LT and CMR organization to ensure the team has access to critical knowledge required for cross CMR engagement.

The leader will be responsible for leading a team to deliver on the responsibility of the area and will be accountable for securing resources, leading according to the Novo Nordisk Way and leadership competencies. In their role as the leader for driving the foundational learning strategy they will provide valuable support and consultation to Senior Leaders in the Line of Business. In this role, the Director will demonstrate exceptional ability to proactively partner with and appropriately influence key leaders and HR organization.

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, 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&eD training initiatives.

Essential Functions

Responsible for leading the strategy, development, 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. Including the development and management of cross-CMR training and education to ensure strong foundational knowledge across all CMR functions to maximize operational efficiency between functional areas (e.g., in new Therapeutic Areas)

Responsible for leading the strategy, development, 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

Ensures 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

Develops requests for proposals; evaluates and provides input into vendor selection based on costs, qualifications and other pertinent factors based on the project; and coordinates legal review of finalized contract; Manages vendors to ensure the seamless integration of high-quality vendor products with the learning curriculum

Collaborates 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

Demonstrates technical expertise within functional responsibility area, staying up-to-date of new approaches & practices and building knowledge of emerging trends and advances within area

Builds and maintains trusting, collaborative relationships and alliances with others inside and outside of the organization, which helps accomplish key business objectives

Physical Requirements

20-30% overnight travel required.

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 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 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.

Source : Novo Nordisk