Manager - Case Review & Compliance Reporting

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

To ensure oversight and management of all contract and vendor related activities in Patient Safety including, but not limited to the following: contractual arrangement support and vendor support in regards to safety reporting. Serves as a liaison between Novo Nordisk Inc., (NNI) Patient Safety Group and other departments on Safety Data Exchange Agreement (SDEA) related matters. To contribute and support activities related to Adverse Event reporting and quality tasks in order to ensure consistency and compliance in all activities performed by Patient Safety.

Relationships

This position reports to the Director, Case Review & Compliance Reporting within Patient Safety.

This position works closely with including, but not limited to the following: all units in Patient Safety, NNI GXP Support, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance as well as with counterparts in Global Safety. External relationships include interactions with NNI business partners, suppliers, healthcare professionals and with FDA personnel concerning Patient Safety reporting matters related to contracts and SDEA requirements.

Essential Functions

• Provide backup support in review and preparation of Quality Management Review (QMR) reporting content for Patient Safety and Global Safety, as needed
• Provide backup support in preparation of monthly internal KPI monitoring report and Time Limit Exceeding updates for Head of Patient Safety. Reports/updates require analysis of late cases that occur during the month, preparing root cause analyses, review the data for trends and make recommendations for process changes and other corrective actions to prevent future late reporting and ensure FDA reporting compliance, as needed
• Guides the successful completion of major programs or initiatives and may function in a project leadership role
• Administration:
  • Exercises considerable latitude and applies extensive technical expertise in determining and implementing strategies consistent with the unit’s functional and corporate goals
  • Manages Patient Safety’s responsibilities and maintains oversight toward Patient Support Programs, Market Research Programs, call centers, digital health initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, management of SDEA requirements, and supplier relations
  • Supports internal and external training activities related to contract and vendor management
  • Provides guidance to contract owners and other stakeholders on safety reporting requirements, including Safety Data Exchange Agreements
  • Liaises with outside vendors and corporate partners on all safety monitoring and reporting issues as appropriate
  • Guides the successful completion of major programs or initiatives and may function in a project leadership role
  • Collaborates with other units within Patient Safety, other business areas at NNI and Global Safety to ensure late reports have been correctly identified and reported to management, as needed. Directs employees on proper root cause analysis, identification, documentation, correction, and corrective action, as appropriate
  • Provide backup support in preparation of monthly internal KPI monitoring report and Time Limit Exceeding updates for Head of Patient Safety. Reports/updates require analysis of late cases that occur during the month, preparing root cause analyses, review the data for trends and make recommendations for process changes and other corrective actions to prevent future late reporting and ensure FDA reporting compliance, as needed
  • Provide backup support in review and preparation of Quality Management Review (QMR) reporting content for Patient Safety and Global Safety, as needed
• Provides guidance to contract owners and other stakeholders on safety reporting requirements, including Safety Data Exchange Agreements
• Manages Patient Safety’s responsibilities and maintains oversight toward Patient Support Programs, Market Research Programs, call centers, digital health initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, management of SDEA requirements, and supplier relations
• Collaborates with other units within Patient Safety, other business areas at NNI and Global Safety to ensure late reports have been correctly identified and reported to management, as needed. Directs employees on proper root cause analysis, identification, documentation, correction, and corrective action, as appropriate
• Exercises considerable latitude and applies extensive technical expertise in determining and implementing strategies consistent with the unit’s functional and corporate goals
• Supports internal and external training activities related to contract and vendor management
• Liaises with outside vendors and corporate partners on all safety monitoring and reporting issues as appropriate

• Assists with the processing and submission of expedited safety reports as needed
• Maintains high state of knowledge of Adverse Event regulations, guidelines and standards related to Adverse Event surveillance and regulatory reporting
• 
  Regulatory compliance:
  • Ensures compliance with all Federal regulations and company SOPs regarding adverse event reporting from both post-marketing sources and clinical trials complaint handling
  • Assists with the processing and submission of expedited safety reports as needed
  • Develops and maintains company (safety) SOPs
  • Maintains high state of knowledge of Adverse Event regulations, guidelines and standards related to Adverse Event surveillance and regulatory reporting
• Develops and maintains company (safety) SOPs
• Ensures compliance with all Federal regulations and company SOPs regarding adverse event reporting from both post-marketing sources and clinical trials complaint handling

• Serves as primary contact, facilitator, and communicator of information to other departments within NNI and NNAS concerning contracts, vendors and SDEA requirements related matters
• Business partner liaison:
  • Liaises with outside vendors and corporate partners on safety monitoring issues as appropriate
  • Serves as primary contact, facilitator, and communicator of information to other departments within NNI and NNAS concerning contracts, vendors and SDEA requirements related matters
• Liaises with outside vendors and corporate partners on safety monitoring issues as appropriate

Physical Requirements

0-10% overnight travel required.

Qualifications

• Knowledge of diabetes, obesity, diabetes and/or obesity management preferred
• Excellent oral and written communication skills
• Knowledge of FDA safety and GMP regulations
• A Bachelor’s Degree in medical or life science area with a minimum of 8 years’ experience required; or a RN or R.Ph with a minimum of 5 years’ experience, including 3 years in clinical and/or safety reporting. Advanced degree preferred
• An MD or PharmD in lieu of RN, RPh, or bachelor’s would be acceptable equivalent experience
• Prefer experience leading projects in a clinical and/or safety area
• Excellent organizational skills
• Previous pharmaceutical industry experience in contract or alliance management preferred

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.