Ranjith Kumar Email & Phone Number

• To author Clinical Study Reports for Phase 1-4 trials, including full study reports and abbreviated reports• To help in drafting Clinical Trial protocols• Ensure high quality, timely communication and project information flow to the Head, Scientific support clinical• To help in drafting Investigators Brochure and IB updates once clinical strategy is finalized.• To assist in template development and management of company specific templates• To assist in maintaining a standard format for various types of documents those are needed for regulatory submission• To provide research information required for a particular therapeutic area available to all team members as required• Perform Quality control of written documents and ensure they meet the required standards• Development of SOPs and processes for Medical Writing in compliance to regulatory requirements

Listed skills include Ich Gcp, Medical Writing, Clinical Research, Regulatory Guidelines, and 2 others.

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  Birla Institute Of Technology

  First Class