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Are you passionate about clinical research writing and regulatory documentation? Virtusa, a leading global IT and digital engineering services company, is hiring Clinical Document Authors for its teams in Bengaluru and Gurugram. This hybrid, contract-based role is ideal for professionals with 1–5 years of experience in authoring protocols, informed consent forms (ICFs), and clinical study reports.
With exposure to FDA, EMA, and ICH-GCP guidelines, this role offers an excellent opportunity to contribute to clinical trial documentation while working with cross-functional global teams.
📝 Key Responsibilities
As a Clinical Document Author, you will:
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- Author and analyze clinical trial documents including Protocols, ICFs, CSRs, and Summary Reports.
- Draft and refine AI-assisted document generation prompts for efficiency.
- Apply expertise in clinical trial phases, study design, and drug development processes.
- Ensure compliance with FDA, EMA, and ICH-GCP standards.
- Use medical terminologies and ontologies for clarity and accuracy.
- Perform quality checks and deliver tasks on schedule.
- Collaborate with project managers and clinical teams, flagging risks where necessary.
🎓 Qualifications
- Education: Any Graduation (Life Sciences preferred).
- Experience: 1–5 years in clinical documentation, regulatory writing, or medical writing.
- Skills: Knowledge of Protocols, Informed Consent Forms, ICH-GCP, FDA & EMA guidelines.
- Notice Period: Immediate – 15 Days.
- Location: Bengaluru or Gurugram (Hybrid).
🌟 Benefits of Joining
- Opportunity to work with global pharma and biotech clients.
- Hands-on exposure to regulatory documentation and AI-driven authoring.
- Collaborative environment with cross-functional teams.
- Hybrid work flexibility with a contract-based secure role.
📩 How to Apply
Interested candidates can share their updated CVs to:
📧 sushma.n@people-prime.com
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