PK/PD Documentation Specialist (m/w/d)

IQVIA; Paris; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading clinical research provider seeks an experienced professional for document coordination and quality control in Clinical Pharmacology & Pharmacometrics. The role involves ensuring compliance, effective communication with teams, and high-quality document writing to support regulatory processes. Candidates should hold a relevant bachelor's degree and possess substantial experience in the pharmaceutical sector.

Qualifications

• Strong experience in the pharmaceutical or CRO industry.
• Proficient in scientific report writing and document QC procedures.
• Experience in population PK/PD report writing is preferred.

Responsabilités

• Communicate with clinical pharmacology leaders and team members.
• Ensure documents are compliant and inspection-ready.
• Drive document QC processes, manage timelines, and compile review comments.

Connaissances

Project Management

Organizational Skills

Scientific Writing

Document Quality Control

Effective Communication

Formation

Bachelor's degree in health, science, or computer science

Outils

Word Templates

Description du poste

Deliver high-quality coordination of the centralized support by the document service management group for the upload of relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g., population PK/PD data transfer plans, analysis plans, and reports) within the required regulatory system, following global procedures of the client. Perform memo and report strawman support, document quality control (QC), prepare CPP documents for submission or health authority interactions, provide writing support, refine QC processes as defined by the organization, and track operational progress among stakeholders. Services are delivered by applying organizational and scientific writing skills to support document writing and QC in line with applicable guidelines and regulations.

Responsibilities

1. Communicate clearly with clinical pharmacology & pharmacometric leaders and team members.
2. Ensure deliverables are inspection-ready and compliant with relevant requirements.
3. Maintain central planning of PK/PD document writing and QC deliverables.
4. Advise on process improvements supporting interactions between Clinical Pharmacology & Pharmacometrics and the document service management group.
5. Drive PK/PD document shell writing, manage document QC processes, timelines, review reports, compile comments, and follow up on comment resolution in collaboration with the team.
6. Perform PK/PD report QC, manage review process, document within QC checklists, and ensure comment resolution within timelines, aligned with analysis plans and guidelines.
7. Support development of CPP reporting templates, analysis plans, and data transfer plans in partnership with the document service management group.

Education and Experience Requirements/Qualifications:

• Bachelor's degree in health, science, or computer science related field.
• Strong experience in the pharmaceutical or CRO industry.
• Proficient with Word templates and document formatting.
• Experienced in scientific report writing and document QC procedures.
• Excellent project management and organizational skills, with the ability to prioritize multiple projects.
• Proficient in English, with effective oral and written communication skills.
• Experience in population PK/PD report writing and review is preferred.

This role is not eligible for UK visa sponsorship.

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 improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com