Manager - Cmr Knowledge & Technical Advancement

8+ years

Not Disclosed

Plainsboro

10 April 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Manager - CMR Knowledge & 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. The CMR department plays a pivotal role in healthcare-provider interactions, developing and implementing regulatory strategies with the FDA, providing medical education, and collecting data to support efficacy and new product development. Novo Nordisk is committed to helping patients worldwide and finding innovative ways to improve their quality of life.

The Position:
As a Manager in CMR Knowledge & Technical Advancement, you will be responsible for developing role-based training curricula for CMR functions to ensure quality and compliance with ICH/GCP and other regulatory requirements. You will collaborate with functional CMR stakeholders to develop, deploy, and archive training materials, assess training gaps, and identify role-specific learning requirements in partnership with Subject Matter Experts (SMEs). This role involves collaborating with internal and external stakeholders to align and share resources across multiple regions.

Relationships:

Reports to: Associate Director or above within CMR Training & Knowledge Management
Key Collaborations: Global and CMR leaders and stakeholders

Essential Functions:

Ensure CMR employees receive training on regulatory compliance, quality standards, GxP requirements, and industry-specific guidelines.
Identify and address specific technical competency/skill gaps, developing training strategies to close these gaps.
Collaborate with SMEs to ensure training programs align with the latest industry trends, regulations, and best practices.
Facilitate the transfer of critical knowledge from experienced personnel to new employees.
Serve as the CMR Training representative, liaising with global and HQ counterparts to ensure quality and consistency.
Ensure compliance with SOPs, KPIs, and internal processes; track and measure specific CMR technical metrics.

Physical Requirements:

10-20% overnight travel required
May require working on company holidays and weekends

Qualifications:

A Bachelor's degree is required; an advanced degree is preferred.
A minimum of 8 years of progressive experience in CMR is required.
At least 2 years of prior training and development experience is required.
Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, federal and local regulations, and clinical research processes.
Demonstrated competency in coaching and training clinical research staff.
Excellent communication, collaboration, and influencing skills.
Strong customer focus and solution-oriented mindset.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we strive to be the best company for the world, fostering an inclusive culture that celebrates diversity in employees, patients, and communities.

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, or veteran status.

For assistance with the application process, please call 1-855-411-5290. This number is for accommodation requests only and not for inquiring about application status.

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Manager - Cmr Knowledge & Technical Advancement

Job Description

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