Associate Director - Medical Review (remote)

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

Responsible for performing medical review and validation of incoming adverse events, ensuring the correct medical interpretation, including evaluation of expectedness and reportability. Ensures consistency in the evaluation of Adverse Event cases. Assures compliance and fulfillment of the requirements as to the evaluation, reporting and surveillance of clinical and post marketing safety information with US drug and device safety reporting regulations and ICH guidelines and internal procedures. The Associate Director Medical Review will contribute and maintain the safety profile of the company’s product together with HQ.

Relationships

Reports to the Director of Case Review and Compliance Reporting, with cross-functional working relationships within Clinical, Medical, Regulatory and Marketing. Interacts with counterparts in Global Safety. Provides medical and technical information to health care providers relating to patient safety. Serves as an internal advisor regarding safety issues.

Essential Functions

• Liaises with Global Safety, as well as NNI medical, clinical and regulatory, on all relevant safety matters
• Narrative writing, medical evaluation of a case, reconciliation of databases, review of protocols, etc.
• Provide medical input in the safety review of ICSRs where the US affiliate has case processing responsibilities, namely post-marketing sources
• Responsible for performing review of individual safety reports for medical content, evaluation of expectedness/listedness and assessing regulatory status for expedited reporting, and possible signal detection
• Performs aggregate medical review of post-marketing, non-serious adverse events in collaboration with Global Safety
• Handles local aggregate report activities, incl. review and safety input for assigned products, e.g. PSURs, PBRERs, PADERs
• Provides guidance and expertise to case processing personnel in triaging and evaluating adverse events and malfunction report with respect to assessment of seriousness, expectedness/listedness, and causality for FDA reportability. Serves as Patient Safety lead SME in PRB meetings for all assigned NN products
• Responsible for the determination of regulatory submissions for ICSRs and performs the quality check of the assessments in collaboration with the case processing teams
• Supports internal and external training activities such as Introduction program for new employees in Patient Safety, annual safety training for Patient Safety employees,etc.
• Complies with all Federal regulations and company SOPs regarding complaint handling and regulatory reporting for adverse experiences, marketed product and clinical investigations
• Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety surveillance and FDA reportability
• Performs gap analysis and impact assessment on new and revised regulatory reporting and safety surveillance regulations and guidelines issued by the FDA
• Provides Patient Safety input to assigned products Local Labeling Committee