Expert Regulatory Writer

Role Overview: As a Medical Writer at Novartis, 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. Key Responsibilities: - 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. - Leading writing teams for complex submissions, contributing to key messaging and strategy, and ensuring compliance with internal company standards and external regulatory guidelines. - Being an ad-hoc member of Clinical Trial Teams (CTTs) and extended member of Safety Management Teams (SMTs), providing input into planning data analyses and presentations used in various documents. - Leading process improvement initiatives, identifying training needs, and fostering a high level of performance within the team. - Communicating effectively, prioritizing tasks, and solving complex problems to ensure success in the role. - Utilizing experience in managing global teams and projects to drive organizational and team performance across cultures. Qualifications Required: - Excellent written and verbal communication skills. - Prior experience in writing and managing clinical and safety documentation. - Strong attention to detail and ability to prioritize tasks effectively. - Experience in providing consultancy and mentoring less experienced writers. - Ability to lead process improvement initiatives and drive organizational performance. - Experience in managing global teams and projects. (Note: Additional details about Novartis and its commitment to personal and professional growth can be found on the Novartis website at [Novartis People and Culture](https://www.novartis.com/about/strategy/people-and-culture). For career opportunities and benefits at Novartis, interested individuals can explore the Novartis Talent Community at [Novartis Talent Community](https://talentnetwork.novartis.com/network) and refer to the handbook on benefits and rewards at [Novartis Benefits and Rewards](https://www.novartis.com/careers/benefits-rewards).),