Expert Regulatory Writer

As a Medical Writer at our organization, your primary responsibility will be to write, review, and manage the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Additionally, you will provide authoritative documentation-related consultancy to other line functions and coach/mentor less experienced writers as needed. Your major accountabilities will include authoring, reviewing, and managing high-quality clinical and safety documents such as complex Clinical Study Reports (CSRs), Risk Management Plans (RMP), and various submission documents for health authorities. You will lead writing teams for complex submissions, contribute to key messaging and strategy, and ensure compliance with internal company standards and external regulatory guidelines. In this role, you will be an ad-hoc member of Clinical Trial Teams (CTTs) and extended member of Safety Management Teams (SMTs). You will also provide input into planning data analyses and presentations used in various documents. Your expertise in documentation will be crucial in ensuring compliance with standards and guidelines, as well as providing strategic guidance for clinical portions of submissions. You will also be responsible for leading process improvement initiatives, identifying training needs, and fostering a high level of performance within the team. Your ability to communicate effectively, prioritize tasks, and solve complex problems will be essential for success in this role. Additionally, your experience in managing global teams and projects will be valuable in driving organizational and team performance across cultures. At Novartis, we are dedicated to helping people with diseases and their families by combining innovative science with a community of smart, passionate individuals like yourself. If you are ready to collaborate, support, and inspire others to achieve breakthroughs that change patients" lives, we invite you to join our network and create a brighter future together. For more information about Novartis and our commitment to personal and professional growth, please visit our website at [Novartis People and Culture](https://www.novartis.com/about/strategy/people-and-culture). If you are interested in exploring career opportunities at Novartis, please sign up to our talent community to stay connected and be informed about suitable roles as they become available: [Novartis Talent Community](https://talentnetwork.novartis.com/network). To learn more about the benefits and rewards of working at Novartis, please refer to our handbook: [Novartis Benefits and Rewards](https://www.novartis.com/careers/benefits-rewards).,