Clinical Document Author – Virtusa (Bengaluru & Gurugram | Hybrid, Contract Role)

About Virtusa

Virtusa is a global leader in IT and digital engineering services, partnering with top pharmaceutical and biotech companies to deliver transformative solutions. We are currently hiring Clinical Document Authors for our teams in Bengaluru and Gurugram. This hybrid, contract-based role is perfect for professionals eager to shape high-quality regulatory and clinical documentation.

Key Responsibilities

As a Clinical Document Author, you will:

• Draft and review clinical trial documents including Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and Summary Reports.

• Leverage AI-assisted tools to optimize document drafting and efficiency.

• Apply knowledge of clinical trial phases, study designs, and drug development processes.

• Ensure compliance with FDA, EMA, and ICH-GCP standards.

• Use medical terminologies and ontologies to maintain clarity and accuracy.

• Conduct quality checks, ensuring timely delivery of documentation.

• Collaborate with cross-functional teams and project managers, identifying and escalating risks where needed.

Qualifications

• Education: Graduate in any discipline (Life Sciences preferred).

• Experience: 1–5 years in clinical documentation, regulatory writing, or medical writing.

• Skills: Familiarity with protocols, ICFs, ICH-GCP, FDA, and EMA regulatory frameworks.

• Notice Period: Immediate to 15 days.

• Location: Bengaluru or Gurugram (Hybrid).

Why Join Virtusa?

• Opportunity to work with global pharmaceutical and biotech leaders.

• Gain hands-on experience in regulatory documentation and AI-powered authoring tools.

• Collaborative and innovative work culture.

• Hybrid working model with contract stability.

How to Apply

If you’re ready to advance your career in clinical and regulatory writing, send your updated CV to:
📧 sushma.n@people-prime.com