Teva Medical Writing Associate Job For Pharma, Apply Online
Medical Writing Associate II
Date: Jan 16, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job Id: 60244
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
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, modeling, and simulation studies).
- Ensure that submission of documents is sent to sponsors within designated timeframes.
- Coordinate on the document with all concerned departments to ensure timelines and compliance with regulatory/sponsor requirements for preparation, compilation, and delivery of documents.
- Knowledge of PK/PD and covariates.
- Knowledge of modeling approaches (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 literature. Knowledge to use standardized formats of data sets like SDTM and ADaM.
- Further, prepare and review 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 teleconferences with stakeholders.
- Work within the SOP system, including departmental work instructions.
- Attend to sponsor queries.
- Implement system improvements as required on a day-to-day basis as per business requirements.
- Mentor the team and, as assigned, act as a 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 Pharmacology OR Pharmacometrics OR Pharmaceutical Sciences OR Biopharmaceutics.
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