- Product Quality:
- Acts in role of process Subject Matter Expert (SME) for the product quality process at NNI. Supports internal and external stakeholders with issue resolution in a timely fashion and in a manner which meets their expectations
- Assists in the development and maintenance of the review process for incoming sample product related deviations and queries
- Manages incoming product information and evaluates in accordance with approved SOPs
- Business partnering:
- Communicate direction on a range of uniquely complex issues in a simple and understandable manner to i.e., the stakeholders he/she support
- Demonstrates good judgment in selecting methods and techniques for establishing more simplified solutions for our stakeholders
- Behavioral skills:
- Develop a network of internal relationships
- Demonstrates knowledge of relevant industry standards, regulations and SOPs. Proactively identifies potential challenges and pursues new ideas, solutions, and opportunities
- GxP compliance:
- Is ready to implement new processes and ways of working in compliance with NN global and local SOPs and actively provide feedback to ensure mistakes are used to further optimize and improve the business Physical Requirements 0-10% overnight travel required. Qualifications
- Bachelor's degree required; relevant experience may be substituted for degree, when appropriate and dependent on requirements of the position. Requires a minimum of 6 years of progressively responsible, relevant experience; some experience in area of specialty required
- Demonstrated ability to work independently under direction from manager. Exercises judgement in selection of methods and approaches for a given assignment. Able to plan, schedule, and arrange own tasks in completing objectives
- Demonstrated capability of using best practice and knowledge of internal and/or external business issues to improve products, services, and/or processes 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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Senior Specialist - 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
Effectively diagnose functional issues and provide agile solutions.
Responsible for the tactical execution of quality-based review and disposition for all exceptions related to product distribution and supporting training relative to proper handling of product by e.g., Field Sales Employees.
Responsible for supporting other processes in the Novo Nordisk Quality Management System as well as supporting continuous improvement projects within the department, affiliate, and/or in collaboration with global colleagues.
Relationships
Reports to the Associate Director Product Quality. Regularly interfaces with multiple NNA/S Quality departments. Additional regular stakeholders include the NNI Sales organization and Sample Operations. Facilitates positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g., vendors involved in the product sampling process and routine networking through membership in industry association(s).
Essential Functions
