Cytel QPP Associate Scientist Vacancy – Pharma Candidates Apply

Cytel QPP Associate Scientist Vacancy – Pharma Candidates Apply

Cytel is hiring pharma candidates for the post of Associate Scientist – QPP. Scientist job opening 2022. Candidates with master’s degrees in pharmacy may apply for the job post at Cytel. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

Job Title: Associate Scientist – QPP

Location: IN IN

Qualifications and Experience:

Master of Pharmacy (M. Pharmacy) in Pharmacology/Pharmaceutics/Pharmaceutical technology.

Minimum Work Requirements:

• 1-3 years of hands-on experience in PK 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.
• Should have good academic credits and excellent communication skills (oral and written).

Skills:

• Expertise in WinNonlin® / Phoenix WinNonlin® software in creating workflows independently.
• Demonstrated strong understanding of Drug Discovery and Development, and biopharmaceutics through scientific presentations, posters and publications.
• Proficiency in Medical and Scientific writing.
• Thorough knowledge regarding International Conference on Harmonisation-Good Clinical Practice.

Summary of Job Responsibilities:

• Reads and understands the study protocol, PK analysis specifications worksheet, and project requirements.
• Prepares and understands Pharmacokinetic Analysis Plan (PKAP).
• Merges concentration-time data and performs data cleaning process.
  Creates Non-compartmental analysis (NCA) workflows in Phoenix WinNonlin® 6.3 or higher.
• Creates Tables, Listings, Figures (TLFs), and summary reports for regulatory submission.
• Prepares SAS® transport files for regulatory submission.
  Perform quality control and quality assurance of PK deliverables as per the client assignment specifications.
• Coordinates cross-functional activities involving statisticians, SAS® programmers, and medical writers involved in pharmacokinetic projects.
• Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799, and client’s SOPs.

Apply Online

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