Successful candidate will join the Global Pharmacometrics modelling team within Clinical Pharmacology & Pharmacometrics in delivering high quality support towards centralizing coordination of Pharmacometrics deliverables including reporting of various analyses (e.g., population PK, PK/PD, Model Based Meta Analysis and Quantitative Systems Pharmacology), quality control (QC) process, tracking the operational progress amongst stakeholders, and setting up a framework to facilitate the coordination of these activities. This function liaises closely with pharmacometric leaders, clinical pharmacology leaders, and other team members. Services are delivered by applying management and organizational skills, report writing and scientific QC. Basic knowledge of Pharmacokinetics, Clinical Pharmacology and/or Pharmacometrics concepts is a plus.
Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc. Clear communication with pharmacometric leaders, clinical pharmacology leaders and other team members. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements. Central management of reporting of Pop PK/PKPD Analyses (e.g., planning and ensuring reports get into the required databases). Support writing of PK/PKPD reports and manage review process, including comment resolution. Maintain & continue development of Pharmacometric reporting templates, analysis plans, and data transfer plans, as required. Centralized support of QC process: ensures quality QC of Population PK/PD, MBMA and QSP reports in close collaboration with the Pharmacometrics Leader within projected timelines, in line with internal guidelines and analysis plan. Maintain oversight of outsourced deliverables related to review/reporting. Metrics and workload: facilitate our review of metrics and provide resource tracking for pharmacometrics deliverables. Education and Experience Requirements/Qualifications
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Minimum degree: BA/BS Proficient with templates and report processing tools. Knowledge of reproducible reporting using Rmarkdown. Experience in scientific report writing. Studious and data-driven person with an eye for detail. Proficient in speaking and writing in English. Effective communication skills, oral and written.
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Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc. Clear communication with pharmacometric leaders, clinical pharmacology leaders and other team members. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements. Central management of reporting of Pop PK/PKPD Analyses (e.g., planning and ensuring reports get into the required databases). Support writing of PK/PKPD reports and manage review process, including comment resolution. Maintain & continue development of Pharmacometric reporting templates, analysis plans, and data transfer plans, as required. Centralized support of QC process: ensures quality QC of Population PK/PD, MBMA and QSP reports in close collaboration with the Pharmacometrics Leader within projected timelines, in line with internal guidelines and analysis plan. Maintain oversight of outsourced deliverables related to review/reporting. Metrics and workload: facilitate our review of metrics and provide resource tracking for pharmacometrics deliverables. Education and Experience Requirements/Qualifications
:
Minimum degree: BA/BS Proficient with templates and report processing tools. Knowledge of reproducible reporting using Rmarkdown. Experience in scientific report writing. Studious and data-driven person with an eye for detail. Proficient in speaking and writing in English. Effective communication skills, oral and written.
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