Job title: Manager role Pharmakinetics at Leading MNC
Company: Golden Opportunities Private Limited
Job description: Preferred experience for the role: A minimum of 8-13 years of experience in handling and analysis of PK data is required.
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
Location: Mumbai, Maharashtra
Job date: Wed, 31 Mar 2021 22:08:27 GMT
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