Jen Cohoon

About Jen Cohoon

As a Manager of Global Regulatory Affairs at IQVIA, I oversee and lead the regulatory strategy and project manage regulatory submissions for clinical trials across various therapeutic areas and product categories. I have more than ten years of experience in global regulatory affairs, with expertise in medical device, in vitro diagnostics (IVD), and pharmaceuticals. I am passionate about delivering high-quality and timely regulatory services to clients, ensuring compliance with different regulatory requirements and standards. I have successfully managed and executed multiple regulatory submissions, approvals, and consultations in various regions, including US, Canada, EU, LATAM, and APAC. I have also contributed to business development, project management, staff training, and mentoring within my team and organization.

Experience

1. Manager Global Regulatory Affairs

   IQVIA

   Mar 2023 — Present · US

   Line manager, mentor, and trainer for junior regulatory team members- Oversee regulatory staff\'s projects and utilization (% billable)- Regulatory Management Oversight for global pharmaceutical, device, and IVD studies- Regulatory support for new sales opportunities; presents regulatory services to clients at bid defense meetings and new project awards- Supports requests for new project proposals, budget development, forecasting monthly project hours, and project billing

Education

• Concordia University-Wisconsin

  Master of Business Administration (M.B.A.), Business Administration and Management, General

• University of Wisconsin-Milwaukee

  Bachelor’s Degree, Clinical Laboratory Science/Medical Technology/Technologist

• University of Wisconsin-Milwaukee

  Certificate, Healthcare Informatics