Job Description Summary

Job Description

Major accountabilities:

• Core member of clinical Trial Team/participate in safety Management Team -Actively participate in planning of data analyses and presentation used in CSRs.
• Act as documentation consultant in CTTs and SMTs To ensure compliance of documentation To internal company standards and external regulatory guidelines.
• May Act as Program Writer ensuring adequate medical writing resources are available for assigned Program and consistency between documents.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards -Customer / partner/ project feedback and satisfaction -Adherence to Novartis policy and guidelines

Minimum Requirements:
Work Experience:

• Functional Breadth.
• Cross Cultural Experience.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills:

• Clinical Research.
• Clinical Trials.
• Detail Oriented.
• Medical Writing.
• Regulatory Compliance.
• Safety.

Languages :

• English.

Skills Desired