Posted in Other 30+ days ago.
Type: Full Time
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 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 daily operations of Product Safety's Case Intake or Handling team, which are responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, for Novo Nordisk Inc's (NNI) US marketed products (drugs and devices) and investigational products. They are 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.
Reports to Product Safety Management. Daily internal interactions with personnel from Product Safety, Global Safety, Clinical Trial Management, 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.
- Manage daily workload coordination/distribution for the Case Intake or Handling team
- Ability to perform all responsibilities of more junior staff; perform any and all of these activities when needed to support the team
- Monitor team performance to established work priorities and performance expectations
- Monitor the quality of team deliverables
- Participate in defining and driving the implementation of corrective and preventive actions in response to quality and/or compliance issues
- Maintain up-to-date knowledge and understanding of pharmacovigilance laws, regulations and guidelines and internal NNI procedures and ensures team operates accordingly
- Maintain awareness of business drivers and changes (e.g. new product launches, new regulations, recalls) with potential to affect the team and incorporate them into the processes and plans
- Partner with Product Safety's Safety Intelligence & Compliance team to manage and plan new hire training and assign mentors
- Partner with Product Safety's Case Intake or Hanlding team to address any unmet needs (e.g. unclear or incomplete documentation)
- Collaborate with external vendors regarding contractual provisions for the collection and forwarding of safety information to NNI
- Collaborate with Global Safety on Standard Operating Procedure (SOP) updates and regulatory changes
- Collaborate with Patient Centric Customer Care to assist with training their staff and provide continuous feedback for improvement
- Handle call escalations for all case types and investigate solutions for unique situations by collaborating across the organization
- Manage the collection, analysis and presentation of team metrics
- Serve as Subject Matter Expert during audits/inspections on all processes; take lead role (e.g. document review, coach auditees, manage document requests, scribe)
- 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 and investigate new responses for unique situations
- Identify procedural deficiencies and opportunities for process improvement; make improvement recommendations to management and lead implementation of solutions either independently or by leading a team
- Lead department related projects
0-10% overnight travel required.
Development of People
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.
- 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); advanced degree preferred
- A minimum of 8 years of progressively responsible, relevant experience, with at least 4 years in Product Safety
- People Management experience preferred
- 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)
- Demonstrated leadership skills required
- Experience with audits/inspections required
- Analytical and strategic thinking skills required
- Proficiency in Windows, Microsoft Word, Excel and Outlook required
- Experience with a Call Center and Drug Safety database preferred
- Excellent oral and written communication skills required
- Ability to work with sensitive or confidential information required
- Strong attention to detail required
- Ability to work with minimal supervision 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 all 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..