Main Accountabilities Routine analysis & Stability Analysis (assay, RS, dissolution, water content etc.) of R&D formulation projects (solid & liquid orals, injectables)Daily calibration of pH meters, balances etc.Stability sample management (loading & withdrawal as per stability plan)Preparation of Stability Reports & other protocol based study reports for assigned projects, as applicableHands-on experience of analytical instrumental techniques (H
Main Accountabilities Routine analysis & Stability Analysis (assay, RS, dissolution, water content etc.) of R&D formulation projects (solid & liquid orals, injectables)Daily calibration of pH meters, balances etc.Stability sample management (loading & withdrawal as per stability plan)Preparation of Stability Reports & other protocol based study reports for assigned projects, as applicableHands-on experience of analytical instrumental techniques (H
Key ResponsibilitiesConduct medical review of study related documentsPrepare high quality medical rationale documents for agency submissionPeriodic Safety reviewMedical monitoringDevelop clinical rationale for new products. Competencies and exposure to succeed in the role.Previous experience in medical review of clinical study documents (trial and BA/BE).Knowledge of clinical development for different regulatory such as USFDA, IND, EMA, JFDA.Familiarity wi
Key ResponsibilitiesConduct medical review of study related documentsPrepare high quality medical rationale documents for agency submissionPeriodic Safety reviewMedical monitoringDevelop clinical rationale for new products. Competencies and exposure to succeed in the role.Previous experience in medical review of clinical study documents (trial and BA/BE).Knowledge of clinical development for different regulatory such as USFDA, IND, EMA, JFDA.Familiarity wi