Associate Director, EU Inspection Strategy - (R1046455) in Reading, UK at IQVIA™

Date Posted: 11/10/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
    11/10/2018
  • Job ID:
    R1046455

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.

The Associate Director, EU Inspection Strategy is a key role driving inspection readiness across IQVIA.  The incumbent will drive strategy and management for on-site inspections at IQVIA EU locations, in collaboration with internal and external partners.   The AD, EU Inspection Strategy will also serve a key advisor in regulatory agency interactions and in the proactive mitigation of regulatory risks in clinical and pharmacovigilance-related initiatives and programs.

RESPONSIBILITIES:

 Key responsibilities include:

  • Proactively identify and prioritize regulatory and compliance risks based on deep knowledge of how EU inspectorates interpret and apply regulations. Work with business partners to escalate and support the mitigation of regulatory and compliance risks.  Drive effective mitigation of regulatory and compliance risks in collaboration with Quality Management and operational partners.

  • Provide strategic management of all on-site regulatory agency inspections at IQVIA facilities in the EU.

  • Serve as a regulatory subject matter expert in the review of responses to regulatory agency inspections.

  • Provide support, oversight and strategic guidance for  the successful implementation of regulatory commitments.  Conduct, as necessary, independent assessment of implementation of inspection commitments.

Required Experience:

•        Bachelors’ degree or higher in a scientific or healthcare-related field

•        Demonstrated experience working in a clinical trial or pharmacovigilance-related role within an EU health authority

•        Minimum 5 years of experience in experience in drug development in a pharmaceutical, biotech, or other regulated setting, preferably within a quality or compliance role

•        Demonstrated experience leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility.

Required Skills:

•                 Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies and demonstrated experience interpreting and applying relevant regulations, laws and guidance.

•                 Practical experience applying proactive quality approaches for clinical trials.

•                 Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers

•                 Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience. 

•                 Strategic mindset and demonstrated business acumen



Job Requirements

•        Bachelors’ degree or higher in a scientific or healthcare-related field

•        Demonstrated experience working in a clinical trial or pharmacovigilance-related role within an EU health authority

•        Minimum 5 years of experience in experience in drug development in a pharmaceutical, biotech, or other regulated setting, preferably within a quality or compliance role

•        Demonstrated experience leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility.

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: R1046455