PK/PD Documentation Specialist

IQVIA; Reading; On-site; GBP 35,000 - 45,000; Full time

Job summary

Une entreprise leader dans la recherche clinique recherche un coordinateur de documents pour la pharmacologie clinique. Ce poste implique la rédaction et la révision de documents scientifiques dans le respect des normes et procédures. Les candidats doivent avoir des compétences en gestion de projet et un diplôme en science. Une expérience dans l'industrie pharmaceutique est également requise.

Qualifications

• Expérience solide dans l'industrie pharmaceutique ou CRO.
• Compétences en gestion de projet et en organisation.
• Pratique de la rédaction et des procédures QC des documents scientifiques.

Responsibilities

• Coordination de la rédaction des documents PK/PD et contrôle qualité.
• Communication claire avec les leaders en pharmacologie clinique et l'équipe.
• Gestion des délais de livraison et suivi des commentaires dans le processus de révision.

Skills

Project Management

Document QC Procedures

Scientific Report Writing

Effective Communication

Education

BA/BS Degree in Health, Science, or Computer Science

Tools

Word Templates

Job description

Deliver high quality coordination of the centralized support by the document service management group for upload of relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports) within the required regulatory system per global aligned procedures of client. Perform memo and report strawman support, document quality control (QC), prepare Clinical Pharmacology & Pharmacometrics documents for submission or health authority interactions, provide writing support, implement QC process refinement as defined by the Clinical Pharmacology & Pharmacometrics organization, and track the operational progress amongst 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

• Clear communication with clinical pharmacology & pharmacometric leaders and other team members.
• Ensure deliverables are inspection ready and compliant with relevant requirements.
• Maintain the central planning of population PK/PD document writing and QC deliverables.
• Provide advice/recommendation on process improvements in support of interactions between Clinical Pharmacology & Pharmacometrics and the document service management group.
• Drive the PK/PD document shell writing, document QC process, management of deliverable timelines; receive, and review documents (e.g. reports), compile comments and edits; follow up on comment resolution in close collaboration with the team.
• Provide PK/PD document QC of reports and manage the review process, documentation within QC checklist, including comment resolution follow up, within projected timelines, in line with the analysis plan and internal Johnson & Johnson guidelines.
• Support the development of CPP reporting templates, analysis plans, data transfer plans, as required in close partnership with the document service management group.

Education and Experience Requirements/Qualifications:

• Minimum degree: BA/BS Degree in a health, science, or computer science related field.
• Strong experience working in Pharmaceutical or CRO Industry
• Proficient with word templates and document formatting.
• Experienced in scientific report writing and document QC procedures.
• Project Management and organizational skills, ability to prioritize multiple projects.
• Proficient in speaking and writing in English. Effective communication skills, oral and written.
• Experience in population PK/PD report writing and review is preferred.

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