- 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. 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 anywhere in the United States with reasonable access to a major airport. 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 $130K to $140K. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. The position is eligible for a company car through the Company's FLEET program. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. The job posting is anticipated to close on April 18th, 2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-
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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Remote - Senior Specialist - GXP Support - Plainsboro, United States - Novo Nordisk
Description
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 Harmonisation 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
