Director, Patient Quality Complaints Case Management

Novo Nordisk; Plainsboro Township (NJ); Sur place; USD 187 000 - 300 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

Life insurance

401(k) savings plan

Flexible spending accounts

Employee assistance program

Tuition reimbursement

Résumé du poste

Novo Nordisk is seeking a Director of PQC Case Management in the U.S. to oversee intake, triage, and processing of product quality complaints and related safety information for US post-marketed products.

You will provide strategic leadership and ensure regulatory compliance across the USO safety operations. With oversight of intake managers and PQC staff, you will drive process improvements, KPI achievement, and vendor coordination while collaborating with global teams to protect patient safety

Qualifications

• Bachelor's Degree in Medical or Science-related discipline required, 10+ years in related fields
• Supervisory management experience of at least five years preferred
• SME knowledge of global regulations including FDA and ICH
• Expertise in safety databases, call center telephony systems and quality systems
• Knowledge of Novo Nordisk disease states preferred (e.g., diabetes, obesity)
• Good communication skills and organizational skills are required
• Expertise in Workflow, Budgeting and KPI monitoring

Responsabilités

• Oversee intake and initial triage of safety information across channels
• Lead USO complaint process teams and ensure KPI compliance
• Collaborate with internal/external stakeholders to optimize intake workflows
• Develop and optimize PQC case processing procedures for regulatory compliance
• Lead efforts to train staff and monitor performance metrics
• Manage vendor relationships and escalation processes
• Support safety info processing in databases and cross-functional systems
• Coordinate with patient safety leadership to align with corporate timelines
• Prepare documentation for inspections and ensure inspection readiness
• Forecast resource needs for case intake across channels

Connaissances

Communication

Leadership

Organizational skills

Budgeting

KPI monitoring

Formation

Bachelor's Degree in Medical or Science-related discipline

Outils

Safety databases

Call center telephony

Quality systems

Description du poste

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?

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
The Director, PQC Case Management is responsible, will do direct oversight for ensuring efficient operations for Product Quality Complaints Case Management and Complaint Return Handling. Responsible for the oversight of the receipt, documentation, triage and handling of product quality complaints (PQC) and associated safety information for US Operations (USO) post-marketed products. Also support case management activities within US Patient Safety Team.

Relationships
Reports to the Head of USO Patient Safety, with cross-functional working relationships within Global Customer Complaints, and working relationships within Case Processing, Medical Review, Submissions and Compliance and the centralized teams (e.g., Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). The Director of PQC Case Management will provide strategic and operational leadership related to PQC case processing oversight. The Director of PQC Case Management has direct and indirect oversight of key roles including the Intake manager(s), Triage manager(s), PQC Manager(s), various call handlers and external vendors supporting patient safety, and product quality complaints. This role also encompasses indirect management of PQC case handlers. External relationships include interactions with patients and healthcare professionals. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department objectives.

Essential Functions

• The Director of PQC Case Management is a strategic leader responsible for overseeing the intake and initial triage of all safety information including adverse events, product complaints, and other safety concerns across various channels.
  
• Manage teams and personnel overseeing the USO complaint process.
  
• Collaborate with multiple internal and external stakeholders to optimize intake workflows, enhance data quality, and drive continuous improvement.
  
• Develop, maintain, and continuously optimize procedures and processes for PQC case processing, quality initiatives, complaint returns, and intake to ensure regulatory compliance.
  
• Lead efforts to optimize PQC workflows, implement training and performance metrics, manage vendor relationships, and ensure that frontline teams are equipped to capture and elevate safety information accurately and efficiently.
  
• Oversee complaint returns team; ensuring KPI compliance and process optimization.
  
• Collaborate with patient safety leadership in managing case management activities within safety databases and other supporting systems. Collaborate with NNI Patient Safety Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements
  
• Leads the safety follow-up process with consumers, healthcare professionals, and external vendors to proactively obtain critical case information, ensuring completeness and accuracy for timely processing and ongoing benefit-risk evaluation of Novo Nordisk products
  
• Monitor internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met.
  
• Lead deviation management activities, including root cause analysis and implementation of CAPAs, to mitigate risk and strengthen safety operations.
  
• Support the preparation of SDEAs, PVA and other contract documents in collaboration with other cross functional teams within Strategic Operations.
  
• Forecasts and plans resource requirements for case intake across all channels, ensuring optimal staffing and operational readiness to support timely and compliant safety case processing.
  
• Support inspection readiness by preparing documentation and participating in internal and external inspections.
  
• Serve as the escalation point for safety-related risks, ensuring timely and effective resolution in coordination with relevant stakeholders.
  

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

• Bachelor's Degree in Medical or Science-related discipline, or related field of study from an accredited university and 10+ years of experience is required, related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least six (6) years in pharmacovigilance experience required
  
• Supervisory management experience of at least five years is preferred.
  
• SME knowledge of global regulations including FDA and ICH regulations and guidelines
  
• Expertise in safety databases, call center telephony systems and quality systems.
  
• Knowledge of NNI supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders)
  
• Good communication skills and organizational skills are required
  
• Expertise in Workflow, Budgeting and KPI monitoring
  

The base compensation range for this position is $187,100 to $300,000. 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. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. 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.