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

　　Advanced level position expected to perform all daily operations of Patient Safety's Case processing Team, which is responsible for the receipt, documentation, triage, case review and quality assessment of all inbound safety information, including serious and non-serious adverse events and technical complaints, for Novo Nordisk Inc. (NNI) US marketed products (drugs and devices).

　　Provide day to day management of the Case Processing team

　　Also responsible for ensuring compliance with all internal and external (e.g., FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety records by providing guidance, training and mentorship to all team members

　　Relationships

　　Reports to Patient Safety Director.

　　Daily internal interactions with personnel from Patient Safety, Medical Information, Field Sales, Supply Chain, Customer Complaints Center , Patient Centric Customer Care and Global safety.

　　Daily external interactions with patients, caregivers, health-care professionals and external vendors.

　　Essential Functions

　　Ability to perform all responsibilities of more junior case processing staff, including but not limited to:

　　Processing of serious and non-serious adverse events and associated technical complaints and analysis results related to marketed NNI products into the local intake tool, complaint and global safety databases

　　Handle escalation calls from HCPs and consumers

　　Perform triage, case classification and case assignment, and handle workflow case allocation and oversight

　　Assist with training of new hires within PS and suppliers as needed. Support mentorship activities for case processing

　　Oversight of call monitoring

　　Serve as Subject Matter Expert during audits/inspections on all Case Handling processes and take an active role in the audit/inspection process

　　Collaborate with Global Safety to align on case handling instructions across safety sites by attending relevant global meetings and coordinating dissemination of information and actions

　　Serve as Case Handling Team’s Argus Workflow Manager

　　Review and collect Case handling metrics and provide analysis and presentation.

　　Provide and conduct analysis and processing of Case Handling Key Performance Indicator (KPI) data received from Global Safety

　　Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and lead implementation of solutions

　　Lead departmental related projects

　　Provide overall management of the team in coordination with PS Management Team (e.g. participate in new candidate interviews, workload coordination, attending meetings and assisting with resulting actions which impact the team)

　　Serve as member of the Patient Safety Management team

　　Physical Requirements

　　0-10% overnight travel required.

　　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

　　Bachelors degree required (in medical or science-related discipline) or relevant experience may be substituted for degree, when appropriate

　　A minimum of 8 years of progressively responsible, relevant experience, with at least 4 years in pharmacovigilance required

　　Customer service experience preferred

　　Direct Report management experience required

　　Exceptional knowledge of medical terminology required

　　Knowledge of NNI supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders)

　　Experience with audits/inspections required

　　Analytical thinking skills

　　Proficiency in Windows, Microsoft Word, Excel and Outlook required

　　Experience with a Call Center and Drug Safety database preferred

　　Strong oral and written communication skills

　　Ability to work with sensitive or confidential information

　　Strong attention to detail

　　Ability to handle multiple priorities and demands in a fast-paced environment

　　Strong planning, organizational and time management skills

　　Ability to interact with various levels of the organization

　　Ability to form strong working relationships with stakeholders

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