Senior Director - Cmr Knowledge And Technical Advancement

Novo Nordisk

12+ years

Not Disclosed

Plainsboro

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Director, CMR Knowledge & Technical Advancement (KTA)

Location: North America Operations (US/Canada/Mexico)
Company: Novo Nordisk

About the Department

The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is a cornerstone of the organization, driving patient-centered innovation through regulatory strategies, clinical data collection, and healthcare provider collaboration. By focusing on improving patients' quality of life, CMR exemplifies Novo Nordisk’s commitment to changing lives for a living.

The Position

The Senior Director of CMR Knowledge & Technical Advancement (KTA) serves as a strategic advisor and leader, driving initiatives in onboarding, training, cultural engagement, and GxP/regulatory compliance for the CMR organization in North America. This role supports a comprehensive learning strategy across the US, Canada, Mexico City GBS, and the East Coast Hub (ECH), ensuring alignment with global and HR training plans.

As a member of the CMR Strategic Operations Leadership Team, the Senior Director leads a team responsible for creating cross-functional training programs, fostering operational efficiency, and maintaining critical knowledge resources for CMR’s long-term success.

Key Responsibilities

Training Strategy & Execution

Lead the development and execution of role-specific technical training programs (e.g., GxP, clinical trials, patient safety).
Drive cultural engagement and onboarding initiatives for CMR and non-CMR employees across North America and Global Business Services (GBS) units.
Develop and manage cross-functional training and education plans to ensure operational efficiency, particularly in new therapeutic areas.

Knowledge Management

Implement strategies to identify, track, store, and disseminate critical training documentation.
Ensure compliance with FDA Regulations, ICH Guidelines, and Good Clinical Practices (GCPs).

Leadership & Collaboration

Supervise and mentor a team of Learning Support Partners, technical trainers, and knowledge management staff.
Collaborate with internal and external stakeholders, including global development teams, HR, and external vendors, to meet training needs and implement solutions.

Process Development & Compliance

Develop training curricula, job training matrices, and evaluation frameworks for continuous improvement.
Maintain compliance across clinical development, medical, and regulatory processes.
Ensure alignment with global and HR onboarding and training initiatives.

Vendor Management

Oversee vendor selection, contract negotiation, and product integration into the training curriculum.

Budget & Resource Management

Manage departmental budgets and prepare documentation for budget reviews.

Qualifications

Education

Bachelor’s degree required (BA/BS).
Advanced degree in a related field preferred.

Experience

12+ years of experience in training and knowledge management within the pharmaceutical industry.
5+ years of managerial experience, including coaching, cross-functional collaboration, and strategy implementation.
Proven track record in developing and managing technical training programs and GxP compliance.

Skills & Expertise

Deep knowledge of FDA Regulations, ICH Guidelines, and GCPs governing clinical trials.
Experience in training needs assessments, material development, and cultural engagement strategies.
Familiarity with digital training tools and knowledge management systems.
Exceptional leadership, communication, and cross-functional collaboration skills.

Attributes

Demonstrated ability to manage global training initiatives and align them with organizational goals.
Commitment to fostering an inclusive, patient-centered culture.

Physical Requirements

20–30% overnight travel, including international travel as needed.

Equal Opportunity Employer

Novo Nordisk is committed to fostering diversity, equity, and inclusion. We provide equal opportunities to all applicants regardless of race, gender, ethnicity, religion, disability, or veteran status.

If you require accommodations to apply, contact us at 1-855-411-5290 (for accommodation requests only).

Apply Now: Novo Nordisk Careers

Together, we’re life-changing.

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