Sujatha Ramanathan

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

Experience

1. Expert Regulatory Writer

   Novartis

   Jan 2019 — Present · East Hanover, NJ, US

Education

• University at Albany

  MPH, Epidemiology

  2002 — 2004

Skills

• Clinical Research
• Drug Development
• Good Clinical Practice (Gcp)
• Cancer
• Gcp
• Pharmacovigilance
• Clinical Study Design
• Medical Writing
• Infectious Diseases
• Immunology
• Clinical Development
• Ich-Gcp
• Standard Operating Procedure (Sop)
• Project Delivery
• Oncology
• Protocol
• CRO
• Regulatory Documentation
• Clinical Trials
• Medical Affairs
• Medical Communications
• Project Management
• Therapeutic Areas
• Ctms
• Pharmaceutical Industry
• Sop
• Drug Safety
• Clinical Data Management
• Regulatory Submissions
• Leadership
• Regulatory Affairs
• Project Execution