Regulatory Operations Coordinator at IQVIA

Livingston, Scotland, United Kingdom

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

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

Responsibilities

Ensuring the study documentation is accurate, complete, and well organized in accordance with internal and regulatory standards
Supporting internal and external stakeholders to ensure study set up and site initiation as detailed in the protocol documentation
Supporting internal and external stakeholders to ensure qualification visits are scheduled
Partnering with management to ensure training records for lab staff dedicated to the study are up to date
Filing deviation documentation, as needed. May participate in investigation and resolution
Supporting six sigma, quality, and safety initiatives
Partnering with lab management to ensure sample analysis in accordance with study timelines

Skills

Good Documentation Practices

Laboratory Workflows

Regulatory Standards

Stakeholder Management

Deviation Documentation

Six Sigma

Quality Initiatives

Sample Analysis

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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