Regulatory Operations Coordinator

Regulatory Operations Coordinator

IQIVIA Laboratories

Office-based

IQVIA Laboratories is a global leader in drug discovery and development, offering comprehensive central and specialty biomarker services. Our expertise includes genomics, immunoassays, flow cytometry, anatomic pathology, precision medicine, vaccine assays, ADME, and bioanalytical services. We also specialize in antibody and biomarker discovery and decentralized clinical trial solutions. Committed to scientific rigor and operational excellence, we support all phases of drug development, ensuring high data integrity and accelerating transformative therapies.

Join us on our exciting journey!   

Job Overview: 

Responsible for ensuring the study documentation is accurate, complete, and well organized in accordance with internal and regulatory standards

Supports internal and external stakeholders to ensure study set up and site initiation as detailed in the protocol documentation.

Supports with internal and external stakeholders to ensure qualification visits are scheduled.

Partners with management to ensure training records for lab staff dedicated to the study are up to date.

Files deviation documentation, as needed. May participate in investigation and resolution.

Responsible for supporting six sigma, quality, and safety initiatives.

Partners with lab management to ensure sample analysis in accordance with study timelines.

Requirements:  

• Bachelor's Degree or other equivalent combination of education and experience.

• 6 months experience in a regulated laboratory environment.

• Sound knowledge of good documentation practices.

• Working knowledge of laboratory workflows.

• Ability to build and maintain effective relationships with colleagues and clients.

Join IQVIA to see where your skills can take you  

• Global exposure  

• Variety of therapeutic areas 

• Collaborative and supportive team environment  

• Access to cutting-edge and innovative, in-house technology 

• Excellent career development and progression opportunities  

• Work-Life Balance, with a strong focus on a positive well-being.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com