Job Description
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, 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 pharmacology OR Pharmacometrics OR Pharmaceutical sciences OR Biopharmaceutics
Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
