Swetha Ramoju

• Developing comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
• Monitoring progress against established goals, adjusting schedules and resources as needed to keep projects on track.
• Developing strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
• Identifying plans and resources required to meet project goals and objectives.
• Collaborating closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contribute to overall business growth.
• Coordinate with cross-functional teams to resolve project issues and mitigate risks.
• Provide detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines.
• Coordinate material procurement and required services for projects within budget requirements.
• Implemente continuous improvement initiatives to optimize project outcomes while maintaining costeffectiveness.
• Successfully manage multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
• Planning, designing, and scheduling phases for large projects.
• Meeting project deadlines without sacrificing build quality or workplace safety.
• Establishing effective communication among team members for enhanced collaboration and successful project completion.

• Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
• Planned, designed, and scheduled phases for large projects.
• Met project deadlines without sacrificing build quality or workplace safety.
• Established effective communication among team members for enhanced collaboration and successful project completion.

• Write and edit clinical documents like study reports, protocols, safety reports.
• Review listings, graphs other data as per Statistical analysis plan and clinical protocols.
• Spearheaded efforts to optimize existing templates for consistency across all documents produced by the department.
• Ensured compliance with industry guidelines and regulations by closely adhering to established writing standards and processes.
• Supported successful product launches through timely completion of essential regulatory documents required for approval processes.
• Improved internal communication by creating well-organized standard operating procedures for the medical writing team.

• Involved in the formulation development of various solid and liquid oral formulations.
• Involved in preparation and review of high-quality documentation, product development reports for Regulatory submission.
• Preparation of amendments in response to the complete response, Information request and easily correctable deficiencies letters issued by regulatory authorities.
• Thorough understanding of Drug Master Files and identification of, to be e-published documents against the regulatory requirements throughout product life-cycle.
• Investigation of market complaints of various products (EU/US markets).
• Evaluation and Proposal for Shelf-life extensions feasibility for various formulations.
• Initiation and Proposal for specifications for finished products.
• Ensure the content, quality of analytical reports as per pharmacopoeia specification, Standard Testing Procedures, Batch Manufacturing Records, Stability protocols.
• Identify and propose solutions to resolve issues and questions arising during the formulation development process, including resolution or escalation as appropriate.
• Involved in the review of Target product profiles and preparation of strategic drug development plans.
• Proven experience in cross functional work management.
• Understanding on working with information management systems, project management systems and/or reporting tools.
• Streamlined research processes to meet tight deadlines for multiple projects.
• Streamlined laboratory workflows, resulting in reduced costs and increased productivity.
• Completed testing projects by deadline and under budget for company-wide initiatives.
• Documented and reported test results after making graphical solutions and representations.

• GPKPD Team - Worked on 'Assessment of impact of age, gender and food on PK of a highly variable drug'
• Handling clinical PK/PD data and creating a database
• Phoenix win- nonlin execution; Nonlinear mixed effect modeling basics
• Established support to Global pharmacokinetics-Pharmacodynamics scientists

Summary of project: The factors age, gender and food were found to have small quantifiable impact on PK parameters. However the magnitude of impact was insignificant from PK point of view

• Understanding on Modified release initiatives of various Novartis Pharma products: Various reasons for the development of MR formulations were studied and justified
• Worked on the development of clinical PK/PD study database: Clinical database was developed and a user friendly interface was developed.