Novartis hiring Senior Regulatory Writer

Welcome to Novartis – a global healthcare company with a mission to bring innovative medicines to patients worldwide. At Novartis, we value diversity and inclusion, creating an outstanding work environment where talented professionals collaborate to make a positive impact on people’s lives. We are currently seeking a skilled and experienced individual to join our dynamic team as a Senior Regulatory Writer.

About the Company (Novartis):

Novartis is a leading pharmaceutical company committed to advancing medical science and digital innovation. In 2020, our medicines touched 769 million lives, and we continue to explore new insights and solutions at the intersection of science and technology. Our inclusive and unbossed culture, fueled by integrity and curiosity, empowers our teams to tackle the world’s toughest medical challenges.

Job Description:

As a Senior Regulatory Writer at Novartis, you will be an integral part of the Regulatory Writing and Submissions (RWS) team. Your responsibilities include:

• Authoring, reviewing, and managing high-quality clinical and safety documents.
• Serving as a core member of Clinical Trial Team (CTT) and contributor to Safety Management Team.
• Acting as a documentation specialist in CTTs and Clinical Submission Teams (CST).
• Leading the writing for simple submissions and contributing to key messaging and pooling strategy.
• Driving process improvement in RWS and/or cross-functional initiatives.

Role: Senior Regulatory Writer

Industry Type: Pharmaceutical/Healthcare

Department: Regulatory Writing and Submissions (RWS)

Employment Type: Full-Time

Role Category: Medical Writing

Educational Background Required:

• ≥ 4 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge.

Key Skills (SEO-Friendly):

• Regulatory writing, Medical writing, Global regulatory environment, Biostatistics, Problem-solving, Communication skills.

Apply online