Senior Regulatory Affairs Specialist, DSMB Expert

20 hours ago


Rockville, Maryland, United States Digital Infuzion Full time
Job Overview

Welcome to Digital Infuzion, where we're dedicated to providing life science researchers with faster insights and health providers with on-demand data and tailored software solutions. As a Senior Regulatory Affairs Specialist, you'll play a critical role in ensuring compliance with regulatory standards and shaping the development of innovative healthcare solutions.

Key Responsibilities
  • Develop and implement Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system.
  • Collaborate with cross-functional teams to ensure comprehensive coverage of all regulatory requirements related to DSMB activities.
  • Implement and monitor quality control procedures to ensure DSMB processes are adhered to and compliant with regulatory guidelines.
Requirements
  • Bachelor's or Master's Degree in a related field.
  • Extensive experience in regulatory compliance and SOP development within clinical research, with a focus on DSMB management or similar regulatory oversight boards.
  • Strong knowledge of FDA/EMA regulations, GCP guidelines, ICH, and regulatory processes related to DSMBs.
  • Proven ability to collaborate with a diverse group of stakeholders.
  • Excellent communication, presentation, and training development skills.
  • Strong attention to detail and commitment to high-quality, compliant processes.

Digital Infuzion, LLC is an Equal Opportunity Employer. EOE/AA/M/F/D/V



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