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Job Description Summary
Job Overview
Perform analysis and reporting of Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. Provide consulting on study design, or other aspects of Clinical Pharmacology projects, clinical development plans, and dossiers for product registration. Assist Clinical Pharmacology management in implementing strategic initiatives.
Essential Functions
● As a project PK Scientist develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings and figures, and clinical study reports for Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies.
● Consult with clients, external IQVIA divisions, and Clinical Pharmacology staff on study design, or other aspects of Clinical Pharmacology projects, and clinical development plans.
● Prepare PK/PD sections of global dossiers for product registration and communicate with local regulatory agencies.
● Ensure quality and timely delivery of the project PK/PD deliverables to IQVIA clients.
● Provide update to the IQVIA Project Manager on status of project PK/PD deliverables.
● Participate on project-related cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer.
● Consult and interact with clients, other IQVIA divisions, and third-party vendors.
● Provide technical training, guidance, and mentorship to lower level and new staff.
● Participate in proposal and budget development for Clinical Pharmacology PK/PD components of business proposals.
● Recommend and assist in implementation of quality control (QC) assessment and procedures and scientific review.
● Assist management in implementing strategic initiatives.
● Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc.
● Perform other duties as assigned by Clinical Pharmacology Management.
Qualifications
● Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field Req Or
● Master's Degree or PharmD in Pharmacy or related field Req
● 5 years experience Req Or
● 7 years experience Req Or
● Equivalent combination of education, training and experience Req
● Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required, current therapeutic environment and drug development trends
● Sound knowledge of appropriate PK/PD standards and processes
● Strong understanding of the principles of the drug development process, ICH GCP, and applicable International and national regulatory requirements
● Good coaching and mentoring skills
● Good problem solving and analytical skills
● Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and SigmaPlot graphics, as well as NONMEM, SPlus and basic SAS programming, as required
● Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills
● Ability to work within a matrix team environment
● Ability to prioritize, and independently coordinate and manage PK/PD component of complex projects
● Ability to interact in a cross-functional and multi-cultural team environment
● Ability to establish and maintain effective working relationships with coworkers, managers and clients