Sovan Mahapatro

Project Management:

Led concurrent projects to ensure alignment with objectives and timely delivery of high-quality outcomes. Coordinated seamlessly with Solution Support, Quality, Legal, IT, and Compliance teams for regulatory compliance and risk mitigation. Oversaw project schedules and timelines, optimizing processes and fostering collaboration between stakeholders. Established team priorities, maintained schedules, and monitored performance. Leveraged data and analytics for informed decision-making and business improvements. Developed performance goals for employees and provided constructive feedback for skill enhancement. Established detailed plans based on broad guidance. Fostered a company culture focused on engagement, collaboration, and continuous learning. Onboarded new employees and facilitated cross-functional collaborations. Managed budgets effectively for optimal financial performance. Implemented robust risk mitigation strategies and cross-trained employees for agility. Achieved departmental goals through strategic planning and performance metrics. Drove operational efficiency with data-driven decision-making and cost control. Maintained positive customer relations and maximized team performance through daily monitoring and mentoring.

Medical Writing | Global Labeling Management:

• Managed team of medical writers, effectively delegating tasks based on individual strengths for maximum efficiency and productivity
• Coordinated with clients and affiliates for document development, ensuring seamless collaboration between teams
• Spearheaded projects related to Regulatory writing (Module 2.4, 2.5, 2.6 and 2.7), Protocol, CSR, ICF across various product types and therapeutic categories. Labeling management such as Company Core Data Sheet (CCDS). SmPC, USPI, PIL. Scientific advisory activities such as Systematic Literature Search (SLS)/Data mining, Niche area of developing report for Genetic therapy products ensuring adherence to regulatory guidelines such as ICH, GCP, GLP, GPVP, GDPR.

Regulatory Intelligence (RI)

• Handled pilot, ad-hoc, CoE RI projects following both pull and push workflow
• Define, lead and oversee team operational plans
• Partner with Global team, Global contractors and SMEs, and strategic partners across various regions to create and deliver RI information to various customers
• Keeping abreast of current data, trends, regulatory knowledge, developments and advances in global regulatory market.
• Supporting SMEs in Impact assessment structure, content analysis and lead discussion based meetings to take agreement within RI team before handing reports to Customer.
• Identify and respond appropriately to issues and problems, providing innovative and effective solutions

Tech-enabled Services

• Part of technical support team for tech-enabled services around MW Report writing module, SLS system, Publishing & Submission, and Dossier templates
• Part of automation, tools and processes for tracking and reporting RI-information

• Conducted quality control of over 170+ diverse medical and regulatory documents (CSR, RMP, SBRA, SAR, RTQs, PIP, BD, ICF, IB, Protocol, Safety Reports, etc) maintaining high standards of accuracy and compliance
• Delivered exceptional written and oral communications, ensuring client satisfaction and meeting project deliverables
• Demonstrated expert proficiency in various writing styles for scientific documents, adhering to Good Clinical Practice (GCP) and Good Documentation Practice (GDP) guidelines.

• Provided extensive project support for medical writing activities (15+) such as protocol writing, clinical overviews, and summaries, ensuring regulatory compliance
• Led team in Medical Writing and Regulatory Information Management System (RIMS), streamlining regulatory clinical and register data operations
• Collaborated with cross-functional teams for Clinical Trial Application (CTA) activities, ensuring compliance with relevant regulations.
• Led Cosmetovigilance and Cosmetic Regulatory submission activities

• Assisted in Phase III & IV studies, ensuring meticulous documentation and adherence to ICH-GCP guidelines.
• Managed over 70+ document developments, Query handling documents and Regulatory support activities.

• Assisted CRC for Phase III & Phase IV Studies
• ECRF handling (Medi-data & Data Labs) & CRF documentation
• Filling Feasibility Reports
• Recording & Maintenance of Essential Documents
• Source Data Documentations
• Informed Consent Procedures
• Ensuring maintenance of all documents as per ICH-GCP guidelines.