Regulatory Relations Specialist jobs in Downey, CA

We are seeking a Senior Regulatory Operations Specialist to join Q² Solutions, IQVIA’s laboratory business in Valencia, CA.

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

As the Regulatory Operations Specialist, you will be acting as a liaison between lab operations and the sponsor to ensure coordination of study logistics. You will be responsible for ensuring the study documentation is accurate, complete, and well organized in accordance with internal and regulatory standards.

What you’ll be doing:

• Coordinating with internal and external stakeholders to ensure study set up and site initiation is as detailed in the protocol documentation and qualification visits are scheduled.
• Organizing documentation from lab analysis in study binder and ensuring study documentation is complete and accurate.
• Planning and hosting monitoring visits with sponsors.
• Filing deviation documentation, as needed and may participate in investigation and resolution.
• Attending study calls to stay abreast of study needs and ensures follow up on assigned actions.
• Ensuring adequate inventory of reagents for training and sample analysis.
• Partnering with management to ensure training records for lab staff dedicated to the study are up to date and ensuring sample analysis in accordance with study timelines.
• Identifying opportunities for process improvement, supporting six sigma, and suggests best practices for effectiveness.

What We Are Looking For:

• Bachelor's Degree.
• 3 years of experience in a regulated laboratory environment.
• Or other equivalent combination of education, training, and experience

The Knowledge, Skills and Abilities needed for this role:

• Sound knowledge of good documentation practices.
• Strong interpersonal, communication, organizational, and time management skills.
• Working knowledge of laboratory workflows.
• Knowledge of Six Sigma principles a plus.

What We Offer You:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees’ physical, mental, and emotional, financial, and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit https://jobs.iqvia.com/benefits.

If you’re looking to unleash your potential, join Q² Solutions, IQVIA’s laboratory business, to help make the extraordinary possible!

Q² Solutions, IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers 

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status