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Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

India and is part of the services arm of Cytel. The services arm of Cytel helps large and medium d global pharmaceutical companies in clinical research services such as biostatistics, clinical programming, pharmacokinetics and medical writing. A motivated and experienced individual with demonstrated expertise and leadership in pharmacometrics in designing, analyzing, and reporting clinical drug development studies are required. Must be proficient in creation and management of datasets and use of major PK/PD software such as Phoenix WinNonlin, NONMEM and NLME . Participate in creating development strategies, analyze, review, interpret and communicate PK/PD results of phase trials and prepare research summary reports for use in regulatory submissions. The Candidate will work as a partner in multi-disciplinary development teams by providing PK/PD expertise. Effective collaborations with DMPK scientists, statisticians and medical writers are of key importance. Extensive scientific track record of publications is desirable, and excellent communication and interaction skills in team environment are essential. Other essential qualities include astute decision making abilities, the ability to drive innovation, build effective professional relationships, and meet goals and deadlines.Summary of Job ResponsibilitiesTo be a team member to execute the clinical pharmacokinetic projects (all phases)Read and understand the study protocol, PK analysis specifications worksheet and project requirementsMerging of concentration-time data, PKS data management, data cleaning process and integration of PKS with WinNonlin / Phoenix WinNonlin software.PK/PD analysis using WinNonlin / Phoenix WinNonlin software as per the specifications.Active role in the planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality delivery.Generation of TLFs and summary reports, etc. ensuring on-time quality delivery.Interpretation of PK results and preparation of pharmacokinetic content for Clinical Study Reports (CSRs).Preparation of SAS transport files for regulatory submission.Perform quality control and quality assurance of PK deliverables as per the client assignment specification.Prepares and maintains meeting minutes and other formal documentation, and participates in the requisite formal communication with clients.Participates in development, enhancement and periodic review of Standard Operating Procedures (SOPs) for PK analysis.Should be proactive to pursue the advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives.Co-ordinate cross-functional activities involving statisticians, SAS programmers and medical writers involved in pharmacokinetic projects.Co-ordinate with the client and US-team for clarity of specifications, data issues, reviews, schedules, etc.Read and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and clients SOPs.Qualifications and ExperienceEducationM.Pharmacy in Pharmacology /Pharmaceutics / Pharmaceutical TechnologyExperience5-8 years of hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using WinNonlin / Phoenix WinNonlin software.Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts.Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications.Hands-on experience on Population PK (POP PK) using NONMEM , Statistical analysis using SASand Medical Writing activities would be an added advantage.Should have good academic credits and communication skills (oral and written)
Degree: M.Pharm. (Pharmacy)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 5-8


Clinical Research | Data Management/ Statistics | Documentation/ Medical Writing | Pharmaceutical Research
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