Life Sciences Regulatory Writer Job at Novartis, Apply Online. Novartis Jobs. Novartis Regulatory Writer Job. Interested and eligible candidates may check out all the details on the same below:
Job Title: Regulatory Writer
Job Id: 352031BR
Work Location Hyderabad, AP
Job Description
900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.
Your responsibilities include, but are not limited to:
- To author and review high-quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP). Core member of clinical Trial Team/participates in safety Management Team.
- Actively participate in planning data analyses and presentations 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 Programs and consistency between documents.
Minimum requirements
- A minimum university life science degree or equivalent is required. An advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- ≥ 2 years of medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus a 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.