Novo Nordisk is seeking a Senior Medical Reviewer to join our Centralised Monitoring Unit (CMU) in Bangalore. This role is pivotal in ensuring the highest quality of medical data review across clinical trials, with a strong focus on patient safety, protocol compliance, and adherence to Good Clinical Practice (GCP).
As a Senior Medical Reviewer, you will:
- Conduct comprehensive medical reviews of clinical trial data across various therapeutic areas.
- Ensure compliance with ICH guidelines, GCP, and regulatory requirements.
- Collaborate with Data Managers, Trial Managers, and Medical Specialists to resolve medical inconsistencies.
- Contribute to trial planning, risk-based monitoring, and medical data cleaning.
- Provide training and mentorship to new team members.
- Develop and review Medical Monitoring Plans (MMPs) and data visualization tools.
Key Responsibilities
✔ Perform quality checks on medical reviews and escalate critical findings.
✔ Clarify and resolve medical concerns with investigational sites.
✔ Document medical reviews in the Trial Master File (TMF).
✔ Support risk-based monitoring by identifying clinically significant outliers.
✔ Collaborate with global teams (Denmark HQ) to ensure trial integrity.
✔ Assist in project management and process improvements.
Qualifications & Skills Required
Education & Experience
- MBBS + MD (preferred) in Medicine or related clinical fields.
- 3+ years in Clinical Drug Development (Medical Review, Medical Monitoring, Safety Surveillance, or Clinical Research).
- 1-2 years of project management experience is essential.
- Strong knowledge of ICH-GCP, regulatory guidelines, and medical terminology.
Technical & Soft Skills
- Proficiency in MS Office, MS Project, and PowerPoint.
- Analytical mindset with strong attention to detail.
- Excellent communication (written & verbal English).
- Ability to work in a dynamic, cross-functional team.
About Novo Nordisk
Novo Nordisk is a global healthcare leader with over 100 years of innovation in defeating chronic diseases like diabetes, obesity, and rare blood disorders. With a presence in 170+ countries, we impact 40+ million patients daily.
Why Join Us?
✅ Global Impact – Contribute to life-changing therapies.
✅ Inclusive Culture – Diversity and collaboration drive innovation.
✅ Career Growth – Continuous learning and leadership opportunities.
How to Apply
📌 Application Deadline: July 7, 2025
