Clinical Pharmacokineticist (FSP - Permanent Homebased)

IQVIA; Greater London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading global provider of clinical research services is seeking a professional to ensure that PK/PD deliverables are compliant and inspection-ready. The role involves document management, assisting with quality control, and facilitating communication between teams. Ideal candidates will have strong report writing skills and familiarity with PK/PD analysis tools, including Phoenix WinNonlin. This is an excellent opportunity to contribute to improving patient outcomes and population health.

Qualifications

• Proficient in document formatting and using Word templates.
• Strong experience in scientific report writing and quality control procedures.
• Solid organizational skills with the ability to prioritize multiple projects.

Responsibilities

• Ensure PK/PD deliverables are compliant and inspection-ready.
• Maintain central planning for documentation and QC deliverables.
• Drive document shell creation and quality control processes.

Skills

Scientific report writing

Document QC procedures

Project management

Communication skills (English)

Use of Word templates

PK/PD report writing

Familiarity with Phoenix WinNonlin

Tools

Phoenix WinNonlin

Job description

Key Responsibilities

• Ensure all PK/PD deliverables are inspection-ready and compliant with relevant requirements and internal guidelines.
• Maintain central planning for population PK/PD document writing and QC deliverables.
• Provide recommendations for process improvements to enhance interactions between CPP and document service management teams.
• Drive PK/PD document shell creation, QC processes, and timeline management.
• Receive and review documents (e.g., reports), compile comments and edits, and follow up on comment resolution in close collaboration with stakeholders.
• Perform QC of PK/PD reports, manage review cycles, and document findings within QC checklists, ensuring timely resolution of comments.
• Support development of CPP reporting templates, analysis plans, and data transfer plans in partnership with document service management.
• Draft and review protocols, PK/PD statistical analysis plans, TLFs/TLF shells, and clinical study reports.
• Conduct Non-Compartmental Analysis (NCA) using Phoenix WinNonlin 8.3.
• Draft and review programming specifications for PK/PD studies.

Skills & Experience

• Proficient in using Word templates and document formatting.
• Strong experience in scientific report writing and document QC procedures.
• Solid project management and organizational skills; ability to prioritize multiple projects effectively.
• Excellent communication skills (oral and written) in English.
• Experience in population PK/PD report writing and review.
• Familiarity with PK/PD analysis tools and processes, including Phoenix WinNonlin.

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 IQVIA jobs site.