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
- Prepare and review of CSR, appendices and other relevant documents (bio summary tables, module 2.7, CS-BE etc.) as per the regulatory/sponsor requirements in the required format.
- Coordinate with all concerned department to ensure timelines and compliance to regulatory/sponsor requirements for preparation, compilation and delivery of reports.
- Preparation of study reports for CE/PK studies, Brand studies
- Attend to medical writing related sponsor queries.
- Prepare amended reports and amendments to the CSR when necessary.
- Electronically generate, review study documents and submission of study reports in CTD/eCTD format as per regulatory requirements.
- Providing coding for all adverse events recorded in the study as per MedDRA® coding system for clinical trials.
- Attend to medical writing related sponsor queries.
- Quality check of the final compiled study reports for delivery.
- Responsible for providing practical training to new recruits regarding the preparation of CSR, appendices and other relevant documents.
- Report to Lead Medical Writing-Reports.
- To carry out other responsibilities as and when assigned by management.
- 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
- Experience: 8+ years in writing reports/technical operations
- Qualification: M.Sc, M.pharm
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.
