Clinical Regulatory Specialist, Device (Contract, Home-Based) - RSS

Iqvia Holdings Inc Morrisville , NC 27560

Posted 3 weeks ago

Unleash Your Potential

It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare.

We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.

Join IQVIA and see where your skills can take you.

Responsibilities include:

  • Prepare and analyze clinical data, journal articles and scientific presentations, as applicable, to support regulatory submissions

  • Manage one or more post-approval, post-market surveillance clinical trials

  • Develop clinical plan strategies and assist in the execution of clinical study protocols, timelines, and budget management

  • Collaborate with Regulatory and Quality Affairs on clinical data analysis and post-market surveillance

  • Support Marketing functions in strategic clinical data needs

  • Ensure compliance of clinical trials with federal and applicable regulatory agency requirements, Good Clinical Practices, and Standard Operating Procedures

Qualifications:

  • 5+ years of experience as a Clinical Research Associate, Clinical Project Manager or equivalent external position

  • Experience in the medical device field preferred; experience in the pharmaceutical industry considered

  • Demonstrated clinical regulatory experience including knowledge of applicable US and OUS regulations and clinical data requirements, and preparation of clinical sections of regulatory submissions for FDA and international agencies.

  • Applied knowledge of project management tools

  • Demonstrated interpersonal, written and oral communication skills

  • Demonstrated organization and planning skills

  • Demonstrated success in a team-based environment preferred

  • Demonstrated knowledge and application of personal computer systems and desktop applications

#LI-Remote

#LI-RW1

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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Clinical Regulatory Specialist, Device (Contract, Home-Based) - RSS

Iqvia Holdings Inc