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

Position is responsible for developing Quality and USO strategic objectives and strong business understanding of the value chain and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from the affiliate perspective when required. This role also provides direct support for continuous improvement initiatives, locally or globally driven, for the covered processes while striving for simplicity and ensuring adherence to regulations and requirements. Communicate direction on a range of uniquely complex issues in a simple and understandable manner to i.e. team members.

 

Relationships

Reports to head of NAO Quality PV Oversight Vendor Assessment Team and is an individual contributor role. Maintains positive rapport and working relationships within and across departments in relationship to business improvement projects. Interacts closely with Marketing & Patient Support Solutions and NNI Patient Safety. External relationships include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s).

 

Essential Functions

Member of NAO Quality PV Oversight Vendor Assessment team with ‘Right First Time’ mindset to effectively perform quality assessments and deliver quality control on identified areas of focus within external pharmacovigilance (PV) partners Responsible for the execution of the NAO Quality PV Oversight vendor assessment plan for NNI Patient Safety Accountable for alignment between vendor assessment team and NNI Patient Safety Contracts and NNI Patient Safety/Global Patient Safety standards and processes as applicable Develops comprehensive, relevant resources (e.g. training program, FAQs) to enable compliance with quality control process requirements across NNI and global as applicable Proactively identifies and escalates risks/quality drift in external vendor and NNI processes to mitigate non-compliance and deviation occurrence Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations Coordinates and supports head of Vendor Assessment team to maintain a Center of Excellence (COE) for vendor quality assessment management Provides SME support to employees working within the quality control process, including consultation on in-process change requests within the scope of the COE Supports and provides input to support regular surveillance, follow-up, and reporting program to ensure process compliance within the scope of the COE Develop and leverages 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 Participates and or provides support to NAO Quality processes including but not limited to internal audits and inspections Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs Maintains current understanding of local/federal laws and applicable regulations applicable (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards (ie. Good Pharmacovigilance Practice (GVP), requirements Maintains proficient understanding of the operational business laws and regulations as they pertain to his/her area of work. Maintains up-to-date knowledge of relevant industry standards and regulations, and company policies and procedures relevant to his/her area of work Provides support to other functional areas within NAO Quality PV Oversight and NAO Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and scientific meetings, as necessary

 

Physical Requirements

Approximately 10% overnight domestic and/or international travel.

 

Qualifications

Education Level: Bachelor’s degree required (healthcare provider required); relevant experience may substitute for degree, when appropriate; advanced degree preferred Experience Level: Requires a minimum of 5 years of progressively responsible related experience, with at least 3 years in PV case processing and/or quality control Specific or technical job skills: PV vendor management/oversight.  PV experience/knowledge preferred Contracting process for PV vendors (e.g. Safety Data Exchange Agreement) Excellent interpersonal skills and ability to interact with staff across all levels Demonstrated ability to work independently without appreciable direction Analytical thinker with capability to identify, evaluate, and resolve complex issues that require reviewing multiple factors to determine proper resolution, with management support as needed Demonstrated problem solving skills, creativity, and initiative

 

 

The base compensation range for this position is $140,000 to $175,000. 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.  
 
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. 

 

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

 

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

 

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.