About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc (NNI) 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 Food & Drug Administration (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?
Responsible for the receipt, documentation, triage and quality assessment of inbound safety information, including non-serious adverse events and technical complaints, for Novo Nordisk Inc.’s (NNI) US marketed products (drugs and devices). 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.
Reports to Product Safety Management. Daily internal interactions with personnel from Product Safety, Medical Information, Field Sales, Supply Chain, Customer Complaints Center and Patient Centric Customer Care. Daily external interactions with patients, caregivers, health-care professionals and external vendors.
- Ability to perform all responsibilities of more junior staff, including but not limited to:
- Collect and document information received from inbound and outbound contacts (verbal and written communications) from and to healthcare professionals, NNI sales personnel, patients, caregivers and vendors related to non-serious adverse events and technical complaints associated with NNI products
- Perform data entry of technical complaints and other safety information
- Facilitate customer replacements and refunds; generate acknowledgement letters
- Scan and archive incoming mail containing safety information
- Perform triage, case classification and team assignment
- Handle escalated calls for non-serious adverse events and technical complaints
- Support Case Handling team with reconciliation with vendors and partners
- Assist with training of new hires; mentor new hires
- Perform call monitoring of Product Safety’s non-serious adverse event calls and Patient Centric Customer Care’s safety calls; provide feedback to call handlers
- Perform quality review of technical complaint reports; provide feedback to case handlers
- Process feedback from Customer Complaint Center and Clayton; provide feedback to case intake team
- Serve as Subject Matter Expert for non-serious adverse events and technical complaints during audits/inspections
- Assist with workload coordination/distribution
- Build customer loyalty by providing high quality customer service
- Provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts
- Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and support implementation of solutions
- Assist with department related projects
0-10% overnight travel required. May be required to work company holidays and weekends.
- Bachelor’s degree required (in medical or science-related discipline preferred); relevant experience may be substituted for degree, when appropriate (e.g. Registered Nurse with clinical experience)
- A minimum of 2 years of progressively responsible, relevant experience; Product Safety experience preferred
- A minimum of 2 years of Customer Service experience required
- Strong knowledge of medical terminology required
- Knowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)
- Experience with audits/inspections preferred
- Analytical thinking skills required
- 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 required
- Ability to work with sensitive or confidential information required
- Strong attention to detail required
- Ability to handle multiple priorities and demands in a fast-paced environment required
- Strong planning, organizational and time management skills required
- Ability to interact with various levels of the organization required
- Ability to form strong working relationships with stakeholders required
- Bi-lingual (Spanish-English) a plus
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
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.
Requisition ID: 59783BR
Job Category: Regulatory