Posted to MedZilla on 4/20/2019

Novo Nordisk

US-NJ, Associate Manager - Case Processing Job 545883400A0-MZ


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 and 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?

The Position
Advanced level position expected to perform all daily operations of Product Safety’s Case Handling team, which is responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including serious and non-serious adverse events, for Novo Nordisk Inc.’s (NNI) US marketed products (drugs and devices) and investigational products. 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.

Reports to Product Safety Management. Daily internal interactions with personnel from Product Safety, Clinical Trial Management, Medical Information, Field Sales, Customer Complaints Center and Patient Centric Customer Care. Daily external interactions with patients, caregivers, health-care professionals and external vendors.

Essential Functions
  • Ability to perform all responsibilities of more junior staff, including but not limited to: Full processing of serious and non-serious adverse events and associated technical complaints and analysis results related to marketed and investigational NNI products into the complaint and global safety databases, including but not limited to: Duplicate searches; Product coding; MedDRA coding; Narrative generation; Labeling assessment according to the current approved product label
  • Perform verification of non-serious adverse events and associated technical complaints and provide ongoing feedback regarding case quality to case handlers to support their continued development and ensure excellent case quality
  • Manage all outbound letters and inbound Return to Sender letters
  • Collect and document information received during outbound follow-up calls
  • Generate acknowledgement and follow-up letters
  • Perform triage, case classification and case assignment
  • Assist with training of new hires; mentor new hires
  • Perform reconciliations
  • Perform clean-up of cases in preparation for aggregate reports and in response to quality check output; disseminate learnings to the team
  • Assist with management of workload coordination/distribution for the Case Handling Team
  • Work closely with Safety Intelligence & Compliance team in providing new hire training
  • Perform verification of serious and non-serious adverse event reports; provide feedback to case handlers, identify trends and implement corrective actions
  • Review results of call monitoring for team members with Case Intake team; notify team members of results and identify corrective actions if needed
  • Serve as Subject Matter Expert during audits/inspections on all Case Handling processes; take an active role (e.g. document review, coach auditees, manage document requests, scribe)
  • Present safety reporting instructions at Investigator Meetings
  • Collaborate with Global Safety to align on study specific case processing instructions across sites (e.g. conventions and timelines to ensure completion by database lock)
  • Review the GXP List on a daily basis to determine which cases are reportable to the FDA in an expedited manner, includes drugs and devices
  • Serve as Case Handling Team’s Argus Superuser
  • Solicits ideas/concerns from Product Safety
  • Attends relevant meetings
  • Participates in upgrades, boosters and system improvement initiatives
  • Handle call escalations for all case types (e.g. serious, non-serious, technical complaints)
  • Assist with the collection, analysis and presentation of Case Handling team metrics
  • 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 lead implementation of solutions
  • Lead department related projects

Physical Requirements
0-10% overnight travel required. May be required to work company holidays and weekends.

  • Bachelor’s degree required (in medical or science-related discipline); relevant experience may be substituted for degree, when appropriate (e.g. Registered Nurse with clinical experience)
  • A minimum of 6 years of progressively responsible, relevant experience, with at least 3 years in Product Safety
  • A minimum of 2 years of Customer Service 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 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: 59681BR
State/Provinces: Plainsboro
Job Category: Clinical Development

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