Content Writer Specialist for Regulatory Documentation

3 days ago


Hyderabad, Telangana, India Lifelancer Full time

About the Role:

We are seeking a skilled Content Writer to join our team as a Specialist for Regulatory Documentation at Vimta Labs Ltd in Hyderabad, Telangana, India.

Job Overview:

This is a full-time mid-senior level position that requires experience in protocol design, clinical trial management, and regulatory submission.

Key Responsibilities:

  • Design and develop high-quality protocols for clinical trials, including PK/PD study design for biosimilars
  • Create well-structured and concise study reports that meet eCTD requirements for regulatory submissions
  • Collaborate closely with statisticians to review data analysis and study results
  • Handle sponsor, regulatory, and ethics committee queries effectively
  • Utilize expertise in regulatory writing to prepare ICFs and CRFs/eCRFs

Requirements:

To be successful in this role, you should have 2-6 years of experience in medical writing, specifically in protocol design, clinical trial management, and regulatory submission. Proficiency in eCTD requirements and ability to work independently are essential.

What We Offer:

As a Content Writer Specialist, you will receive a competitive salary of approximately ₹10 lakhs per annum, commensurate with your experience and qualifications. Our company offers a dynamic work environment, opportunities for growth and development, and a chance to work on diverse projects.

How to Apply:

If you are a motivated and detail-oriented individual with a passion for medical writing, please submit your resume through our platform at Lifelancer. We look forward to reviewing your application



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