Senior Regulatory Affairs Associate (Home-Based, Europe) - IQVIA Biotech (R1070995) in Milan, Italy at IQVIA™

Date Posted: 7/4/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Milan, Italy
  • Experience:
    Not Specified
  • Date Posted:
    7/4/2019
  • Job ID:
    R1070995

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies).
• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
• Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects. 
• Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate.
• Serve as Novella liaison with central IRBs.
• Perform other related duties as assigned.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1070995