Sujatha Ramanathan
Expert Regulatory Writer @Novartis
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WORK HISTORY
Expert Regulatory Writer @Novartis
East Hanover, NJ, US
EDUCATION
University at Albany
MPH, Epidemiology
SKILLS
ABOUT SUJATHA RAMANATHAN
Write, review and deliver a range of high quality regulatory documents (Submission documents, Clinical Study Reports, patient narratives, Development Safety Update Reports, Risk Management Plans, CTRDs) 2. As a project lead; manage safety deliverables within the IID (Immunology and Infectious Diseases) franchise including training, mentoring and resource allocation3. Maintain metrics and handle customer and stakeholder expectations4. As a Quality Coordinator at Novartis, ensure that processes/projects are in complaince with SOPs and are of a high qualityGoals: Learning all aspects of Clinical Research including Clinical Trial Operations. In addition, donning leadership roles in all aspects of project and people management.Specialties: Clinical Research: Development of a range of Clinical Research Safety Documents (patient narratives, Annual Safety Reports, Clinical Study Reports, Risk Management Plans) and Publication Deliverables (Posters, Abstracts, Manuscripts)Sound scientific and medical knowledge, excellent communication (both oral and written) skills, leadership qualities, self motivated, ambitious and hard working
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