Medical Writer

3 weeks ago


Pune, Maharashtra, India Clini Launch Research Institute Full time

Roles and Responsibilities

At Clini Launch Research Institute, our Medical Writer will be responsible for preparing and submitting regulatory documents, including clinical trial protocols and study reports, in compliance with ICH-GCP and various regulatory agency guidelines.

Key Responsibilities:

  • Preparation of clinical trial protocols and study reports for regulatory submissions
  • Development of investigator brochures and informed consent forms
  • Review and submission of regulatory documents, including amendments and updates
  • Collaboration with cross-functional teams to ensure timely and accurate document submissions

Requirements

  • 2-5 years of experience in clinical research and regulatory document preparation
  • Strong understanding of ICH-GCP and regulatory agency guidelines
  • Excellent writing and communication skills
  • Ability to work in a fast-paced environment and meet deadlines

About Clini Launch Research Institute

Clini Launch Research Institute is a leading contract research organization dedicated to providing high-quality clinical research and regulatory services. We are committed to helping our clients bring innovative treatments to market while ensuring the highest standards of quality and compliance.



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