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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

Developing quality and strategic objectives and strong business understanding of the value chain and customer focus. 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 for NNI Patient Safety processes and 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. Communicate directions on a range of uniquely complex issues in a simple and understandable manner to i.e. team members.

Relationship

Reports to head of North America Operations Quality Pharmacovigilance Oversight. Maintains positive rapport and working relationships within and across departments in relationship to business improvement projects. Interact closely with NNI Patient Safety and NAO Quality Audits & Inspections. External relationships include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Manage experienced quality representatives and/or contingency workers.

Essential Functions

+ Leads and manages the NAO Quality PV Oversight support function for NNI Patient Safety (PS) with ‘Right First Time’ mindset to effectively deliver oversight on identified areas of focus within NNI Patient Safety

+ Accountable for ensuring alignment with NNI PS /Global Patient Safety standards and processes as applicable

+ Function as a Quality Point of Contact /resource promoting knowledge and information sharing to improve the quality mindset and enforce the QMS at all levels within the organization and function within the role of Quality Business Partner where requested by management

+ Develops comprehensive, relevant resources (e.g. training program, FAQs) to enable compliance with QMS process requirements across NNI and global as applicable

+ Proactively identifies 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 collaborates with NNI Patient Safety and/or external vendors to maintain a Center of Excellence (COE) for support oversight

+ Provides leadership and SME support to employees working within the support function, including consultation on in-process change requests within the scope of the COE

+ Develops and executes 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 audits and Health Authority inspections, including readiness activities, to ensure internal/external compliance with requirements/regulations

+ Support, coordinate, and manage root cause analysis, corrective action(s)/preventative action(s) (CAPA) in connection with audit and/or inspection responses, and ensure proper implementation across various areas of the business

+ 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 laws and regulations applicable to Good Pharmacovigilance Practice (GVP) requirements

+ Ensures that all local activities are in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards

+ 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.

Development Of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

+ Education Level:

+ Minimum Bachelor’s degree required (healthcare provider required); relevant experience may substitute for degree, when appropriate; advanced degree preferred

+ Experience Level

+ Requires a minimum of 9 years of progressively responsible related experience, with at least 3 years in PV management of others experience; pharma experience preferred

+ Specific or technical job skills:

+ Extensive PV oversight/management experience

+ Advanced knowledge of Good Pharmacovigilance Practice, local and federal regulations (21 CFR FDA Regulations Post-Marketing), scientific knowledge as it relates to PV through understanding of NN Standard Operating Procedures (SOPs)

+ Advanced knowledge and participation on internal audit/inspection readiness (i.e. FDA PADE inspection)

+ 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 $170,000 to $200,000. 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.