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Teva Medical Writing Associate II India, Karnataka, Bengaluru 497107773
21.01.2025
How you’ll spend your day
- Primary responsibility is to prepare Clinical study reports (Pharmacometrics studies such as population pharmacokinetics (PK), pharmacodynamics (PD, exposure response analysis, modelling and simulation studies)
- Ensure that submission of documents is sent to sponsor within designated timeframes.
- Coordinate on the document with all concerned department to ensure timelines and compliance to regulatory/sponsor requirements for preparation, compilation and delivery of documents.
- Knowledge on PK/PD , covariates.
- Knowledge on modelling approach (software tools like NONMEM, R, Phoenix NLME), types of models (such as compartmental, semi mechanistic, PBPK).
- Interpretation of results in clinical and regulatory contexts. Comparison with prior studies and literatures. Knowledge to use standardized formats of data sets like SDTM and ADaM
- Further to prepare and review of CSR for BA/BE studies, appendices and other relevant documents (bio summary tables, module 2.7, CS-BE etc.) as per the regulatory/sponsor requirements in the required format. Electronically generate, review study documents and submission of study reports in CTD/eCTD format as per regulatory requirements.
- Arrange meetings and teleconference with stakeholders.
- Work within the SOP system including departmental work instructions.
- Attend to sponsor queries.
- System improvements as required on day-to-day basis as per business requirements.
- Mentor team and as assigned, act as subject matter expert (SME)
- Project lead when assigned
Your experience and qualifications
- 2-5 years in writing reports/technical operations
- Master’s degree in clinical pharmacologyORPharmacometricsORPharmaceutical sciences OR Biopharmaceutics
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