Regulatory Document Writer

4 days ago


Mumbai, Maharashtra, India Tata Consultancy Services Limited Full time

Job Title: Data and Documentation Professional

We are seeking a highly skilled Data and Documentation Professional to join our team at Tata Consultancy Services Limited. In this role, you will be responsible for creating high-quality clinical documents necessary for national and international regulatory submissions.

The ideal candidate will have experience in medical writing across different therapeutic areas, including protocol, informed consent documents, clinical study reports, investigator's brochures, and safety documents. They should also be familiar with ICH GCP principles and regulatory requirements.

Responsibilities:

  • Preparation of clinical/safety documents for national and international regulatory submissions
  • Writing and review of scientific/clinical documents
  • Effective coordination and presentation skills
  • Excellent interpersonal, verbal, and written communication skills

Qualifications:

  • Strong knowledge of clinical research domain and regulatory requirements
  • Experience in medical writing across different therapeutic areas
  • Familiarity with ICH GCP principles

How to Apply:

To apply for this exciting opportunity, please submit your resume and a cover letter outlining your qualifications and experience. We look forward to hearing from you



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