Senior Specialist - GXP Support (remote)

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

Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables the company to manage quality effectively across the organization.

This is accomplished by understanding the needs and expectations of internal/external stakeholders, striving for simplicity, making quality a proactive consideration, ensuring compliance with relevant Good x (e.g., clinical, distribution, manufacturing) Practice (GxP), external guidelines (e.g., International Council for Harmonization Guidelines), applicable country regulations (e.g., U.S. Food and Drug Administration Code of Federal Regulations, Health Canada), and escalating quality concerns.

 

Relationships

This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support. Multiple internal relationships exist with personnel at all levels of the business, and other functional groups across NN. External relationships can include clinical trial sites and external vendors.

 

Essential Functions

• Develop and ensure that the QMS is aligned, maintained, and in compliance with local/global set-up and internal/external requirements
• Promote knowledge and information sharing to improve the quality mindset and enforce the QMS at all levels within the organization
• Advise internal stakeholders when questions/issues/situations related to GxP matters arise by investigating, researching, and providing recommendations or solutions to mitigate or resolve, for example across various topics, such as clinical trial management, deviation handling, and product quality
• Develop, execute, and maintain sufficient training to support understanding of the QMS and communicate/present to relevant stakeholders at all levels
• Support and ensure the QMS is continuously improved to manage quality effectively across the organization
• Support audits and Health Authority inspections to ensure internal/external compliance with requirements/regulations
• Act as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites
• Support local/global quality projects to improve the quality system
• Conduct GxP quality visits at clinical trial sites when directed by management to check principles of assuring patient safety, data integrity and regulatory compliance are sufficient
• Monitor and escalate GxP compliance signals and issues to GxP Support management

 

Physical Requirements

40-50% overnight travel required. Driver must maintain a valid driver’s license. Must be in good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. The incumbent can work remotely from anywhere in the United States. 

 

Qualifications

• A minimum of 1 year of on-site monitoring experience required
• A minimum of 6 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required
• A Registered Nurse (RN) or Bachelors degree required (in science-related discipline preferred). Advanced knowledge of Good Clinical Practice (GCPs), ICH Guidelines, federal and local regulations, research process and scientific knowledge as relates to clinical trial conduct through understanding of NN SOP's
• Demonstrated computer skills (MS Office, MS Excel, MS PowerPoint)
• Must have the ability to function independently with minimal supervision
• Previous proven development or line management of CRAs preferred
• Proven a demonstrated competency in coaching and training of clinical research staff
• Strong communication (written and verbal), customer focus, analytical, negotiation, meeting and time management, cross-functional team, understanding of a metrics driven organization and strong leadership skills required

The base compensation range for this position is $125K