Expert Regulatory Writer

As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related consultancy to other line functions and coaching, mentoring, and training less experienced writers. In this position, you will author, review, and independently manage complex Clinical Study Reports (CSR), Risk Management Plans (RMP), and other documents for health authorities. You will lead writing teams for complex submissions, contribute to key messaging and pooling strategy, and ensure compliance of documentation to internal company standards and external regulatory guidelines. Additionally, you will be an ad-hoc member of Clinical Trial Team (CTT) and extended member of Safety Management Team (SMT). You will provide input into planning data analyses, ensure compliance to internal company standards and external regulatory guidelines, and lead process improvement in cross-functional initiatives. Key performance indicators for this role include delivering high-quality clinical and safety documents in a timely manner and in compliance with internal and external standards, as well as completing an adequate volume of work per year according to Key Performance Indicators. To be successful in this role, you should have at least 6 years of medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge. Expert knowledge of the global regulatory environment, excellent communication skills, and the ability to prioritize and manage multiple demands and projects are essential. You should also have proven experience in managing global, cross-functional teams or complex global projects and the ability to motivate and coach people. At Novartis, we are committed to creating a brighter future by helping people with diseases and their families. We believe in collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients" lives. Join our Novartis Network to stay connected and learn about suitable career opportunities as soon as they arise. If you require any reasonable accommodation due to a medical condition or disability during the recruitment process, please contact us at [email protected] Novartis is dedicated to building an outstanding, inclusive work environment that reflects the diversity of the patients and communities we serve.,