Regulatory Writer

2 months ago

Mumbai, India Novartis Full time

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), 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.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**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.

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

India

**Work Location**

Mumbai

**Company/Legal Entity**

Nov Hltcr Shared Services Ind

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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