GxP & PS Compliance Training Manager

Location: Plainsboro

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 healthcare 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

We are seeking a detail-oriented, technically skilled, and passionate Training Manager to join our GxP Compliance & Patient Safety team at Novo Nordisk. This role is responsible for the strategic oversight, administration, governance, and continuous improvement of Novo Nordisk Inc.'s Learning Management System (LMS). This role ensures the LMS effectively supports enterprise learning initiatives, compliance training requirements, and reporting.

The Training Manager serves as the primary business owner for LMS operations, partnering closely with Clinical, Regulatory & Medical (CMR), Information Technology (IT), Sales and other business stakeholders to ensure accuracy in training assignments and reporting. This position is responsible for managing LMS configuration, reporting, and training governance processes while ensuring compliance with applicable regulatory and company requirements.

The ideal candidate will possess a strong command of pharmaceutical regulations, clinical research processes, and GxP quality management systems, combined with exceptional organizational skills and an unwavering commitment to maintaining the highest standards in a highly regulated environment.

Relationships

This position reports to the Associate Director, GxP Compliance & Patient Safety Training.

This role will collaborate cross functionally with Patient Safety, Quality Assurance, Vendor and Contract Management, Information Technology (IT), Finance, and Sales

The Training Manager will drive and maintain positive rapport and working relationships within and across departments in relation to accurate assignment of training requirements, required quality and regulatory reporting and end user support.

Essential Functions

Key Area 1 | LMS Administration & Operations

* Serve as the primary administrator supporting NNI on the enterprise LMS.

* Administer and maintain the LMS for all NNI training programs, ensuring accurate and up-to-date records of participation and completion.

* Support the deployment and maintenance of training programs, curricula, and certification requirements.

* Manage training assignments, learner enrollments, completion tracking, and recurring certification processes.

* Support internal and external stakeholders with issue resolution in a timely fashion and in a manner which meets their expectations.

* Generate training reports and analytics to monitor completion rates, training effectiveness, and compliance metrics.

* Establish and maintain LMS governance standards, processes, and documentation.

* Ensure system compliance with global policies, audit requirements, and applicable regulatory standards.

* Support audits and compliance reviews by producing accurate and timely training records.

* Develop and leverage relationships with HQ SMEs, process management, and system management to influence process and system development in a manner consistent with global / affiliate health authority and/or stakeholder requirements.

* Provide guidance and/or training to less experienced professionals or support staff.

* Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs.

Key Area 2 | Curriculum & Assignment Maintenance

* Implement job specific training curricula tailored to distinct roles within clinical operations, medical affairs, and regulatory affairs.

* Manage training assignments encompassing clinical research documentation, regulatory requirements, Good Clinical Practice (GCP), and medical affairs procedures.

* Partner with Curriculum Managers to implement new curricula and manage updates to existing learning programs, ensuring training requirements are accurately assigned and aligned with role-specific, business, and compliance needs.

* Actively collaborate with SOP team, Content SMEs, and Curriculum Manager to ensure seamless flow of information and documentation from Quality Docs to LMS, as applicable. Alongside SOP team, Content SME, and Curriculum Manager ensure required training is accurately assigned in LMS.

* Partner with business stakeholders and Curriculum Manager to develop and maintain curriculum assignment standards, ensuring training requirements are consistently and accurately deployed across the…