In the ever-evolving landscape of the pharmaceutical industry, the need for effective communication between life sciences experts and regulatory bodies is paramount. Novartis, a global leader in the field of innovative medicines, understands the significance of regulatory writers in shaping the future of healthcare. With over 900 regulatory documents crafted in 2019 alone, the Regulatory Writing and Submissions (RWS) team at Novartis is on a mission to deliver groundbreaking treatments to patients worldwide. If you are a life sciences professional with a passion for impactful medical writing, this could be your chance to join a world-class organization at the forefront of the industry.
The role of regulatory writers at Novartis is crucial in ensuring that the necessary clinical and safety documents meet the highest standards. By collaborating with colleagues from various departments, including Statistics, Data Management, and Clinical Development, regulatory writers analyze data and craft key messaging to obtain approvals from Health Authorities. This article will explore the responsibilities, requirements, and benefits associated with regulatory writing at Novartis, along with the company’s commitment to diversity and inclusion.
2. The Role of Regulatory Writers at Novartis
– Creating High-Quality Clinical and Safety Documents
As a regulatory writer at Novartis, you will be responsible for authoring and reviewing clinical and safety documents. These include non-registration clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP). In addition, you will serve as a core member of clinical Trial Teams and participate in safety Management Teams. By ensuring the accuracy, clarity, and compliance of these documents, you contribute to the development and approval of innovative therapies.
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.
Minimum Requirements for Regulatory Writers
To be eligible for a regulatory writer position at Novartis, certain minimum requirements must be met.
– Educational Background
A minimum university degree in life sciences or an equivalent qualification is necessary for this role. Additionally, an advanced degree or equivalent education/degree in life sciences or healthcare is desirable. Novartis values a strong foundation in the life sciences field to ensure the accuracy and comprehension of complex medical writing.
Minimum university life science degree or equivalent is required. 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.
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