Manager role Pharmakinetics Jobs in Pune at Golden Opportunities Private Limited

Last Updated: Aug 15, 2021 05:10 IST


Company Name
Golden Opportunities Private Limited
Job title
Manager role Pharmakinetics
3-10 Years
Not Mentioned

Job Profile

Job Description:
  • Preferred Educational Qualification for the role: Bachelorsmasters degree/Ph.D. in Statistic Mathematics Life Sciences or related fields 
  • Preferred experience for the role: A minimum of 8-13 years of experience in handling and analysis of PK data is required.
  • In-depth knowledge of clinical development clinical pharmacology and PK/PD is required. Proficient in using WinNonlin or other relevant pharmacokinetic software for PK/PD analysis and SAS.
  • Good communication and interpersonal skills. Skilled in scientific writing and data interpretation

Key Responsibilities:
  • Monitor and support conduct of PK data analysis using software such as WinNonlin and/or NONMEM
  • Play an active role on cross-functional project teams as a PK office representative
  • and provide contributions to the Statistical Analysis Plans and or write separate PK Analysis Plans
  • Contribute to the clinical pharmacology sections of relevant documents such as clinical study protocols clinical study reports investigators brochures briefing documents and regulatory submissions
  • Work closely with regulatory affairs personnel if required to provide PK data in support of regulatory communications and presentations as needed
  • People/project management along with ensuring day to day operations
  • Ensure the optimal quality of deliverables by assigning layers of peer/internal QC before sharing the output with sponsor/client

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Key skills
Preferred experience for the role: A minimum of 8-13 years of experience in handling and analysis of PK data is required.
Last Date

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