Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Regulatory Writer
• To author and review high quality clinical and safety documents: non-registration clinical Study Reports (CSR), Development safety Update Reports (DSUR), Risk Management Plans (RMP)
• 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.
• Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
• ≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
• Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Knowledge of process for and some experience in global registering of drugs (simple submissions).
• Excellent communication skills (written, verbal, presentations). Very good understanding of biostatistics principles.
• Ability to prioritize and manage multiple demands and projects. Ability to define and solve complex problems (“Problem solver”)
• Broad knowledge and future oriented perspective. Proven track record in matrix environment
Experience : ≥ 2 years
Qualification : degree in life sciences
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 20th January, 2021
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