Dear Job Seekers,
Novartis is Hiring for:
Job Title: 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 be ensuring adequate medical writing resources are available for assigned Program and consistency between documents.
- Minimum Requirements 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
Experience: 2 years
Salary: As per the Company Standards