exciting opportunity to work with medical writing teams on regulatory and safety documents, supporting global clinical research and compliance at Merck

Are you a detail-oriented professional with a passion for regulatory compliance and clinical documentation? A global healthcare leader is hiring a Specialist Document Coordinator (Quality Reviewer) in Bangalore, Karnataka. This full-time role offers an exciting opportunity to work with medical writing teams on regulatory and safety documents, supporting global clinical research and compliance.

If you are looking for a career in regulatory affairs, clinical research, or medical writing, this could be your next big move.

📝 Job Responsibilities

As a Specialist / Senior Associate Document Coordinator, your role will include:

• Conducting quality review of clinical and regulatory documents including:
  • Protocols
  • Clinical Study Reports (CSRs)
  • Investigator Brochures
  • Briefing Books
  • Clinical Summary documents
  • Periodic Benefit-Risk Evaluation Reports (PBRER)
  • Development Safety Update Reports (DSUR)
  • Risk Management Plans (RMP)
• Ensuring compliance with ICH-GCP, CTD guidance, and GVP standards.
• Participating in meetings related to medical writing and compliance activities.
• Collaborating with cross-functional teams to improve processes.
• Applying AMA style guide principles for document accuracy and consistency.

🎓 Qualifications

Minimum Requirements:

• Bachelor’s or Master’s degree in Pharma, Life Sciences, Dentistry, or Medicine (BPharm, MPharm, BDS, BSc, MSc, MD, PhD).
• 2–5 years of experience in the pharmaceutical or clinical research industry.
• Strong knowledge of ICH, GCP, CTD, and GVP guidelines.
• Excellent English writing and medical terminology skills.

Preferred Requirements:

• Hands-on experience reviewing regulatory and safety documents.
• Familiarity with AMA style guide.
• Flexible and adaptable to new assignments and learning opportunities.
• Strong team collaboration skills.

🌟 Benefits

• Opportunity to work with a global healthcare leader.
• Professional growth in regulatory affairs and medical writing.
• Collaborative and inclusive workplace culture.
• Exposure to global clinical research standards and compliance processes.

📌 How to Apply

Application Link