Nikkitha S

1. Project Management (Waterfall and Agile) & Product Ownership

a) Creation of project plan, project road map and share time effort estimation.

b)Track overall project performance and customer metrics.

c) Identification of project scope by assessing the regulatory information on eCTD from ICH, national regulatory bodies, and customer feedback on enhancements to the RIM (Regulatory Information Management) Dossier Publishing System).

d) Improved business processes by analyzing current practices and recommending optimization strategies.

e) Identify risks, resolve project challenges and team conflicts, using problem solving skills.

2. Business Analyst

a) Gather and Consolidate market requirements from customers, management, regulatory bodies for evaluation with SME and identification of business requirements for upgrading the RIM Publishing Application to ensure it is compliant with latest regulatory guidelines.

b) Organizing brainstorming sessions with key cross-functional stakeholders to understand and obtain requirements for upgrading Regulatory Intelligence Software.

c) Translating the specifications into comprehensive (FRS) documents as well as capturing business requirements, change requests in the form of user stories (agile) in JIRA tool

d) Creation of mock-up of new features/enhancements with architecture and product developers.

e)Participating in Scrum meetings.

3. Project Coordination and Communication

a) Coordinate with onsite and cross functional teams across different geographical locations on project activities (onsite – offshore model).

b) Drive cross-functional team meetings; conduct JIRA Story grooming session with Software Development and Quality Assurance team.

c) Performed gap analysis between existing systems or processes and desired state, identifying areas for improvement or enhancement.

4. Client Communication & Global Regulatory Authorities (FDA, MHLW, EMA)

a) Demonstrating newly implemented product features to client and training team.

b) Clarify client queries via email and chats.

c) Communicate with FDA, EMA, MHLW and other regulatory agencies on guideline clarifications.

1. Project Management

a) Preparation of project plan, project estimates and closure documents.

b) Share daily and weekly status reports with all the stakeholders.

c) Measure metrics (KPI)such as Test Coverage, Active/escape defects, team performance.

d) Mentored and Lead a team of 4-5 members, Task prioritization and assignment to the team members.

e) Support auditing activities by periodic inspection of data and documents.

2. Quality Assurance

a)Validate the software product/application as per the business requirements and report bugs/glitches. This involves software testing processes – Functional, regression, Integration, E2E, Ad hoc, UAT.

b) Write and execute test scenarios/cases, evaluate test coverage, bug detection. Perform RCA Analysis.

c) Validate hot fixes, patches, multiple build releases.

d) Conduct defect triage calls & Maintain the software application test data.

e)Improved product quality by implementing rigorous testing protocols and identifying areas for improvement.

3. Client Interaction & Business Analysis

a) Derive Functional specifications through client interactions.

b) Prepare FRS document and Test Scenario document.

c) Identification of requirement gaps.

d)Leveraged strong analytical skills in monitoring performance statistics against established benchmarks, identifying opportunities for targeted improvements in specific areas.

e) Present Annual Reports to clients in US

4. Communication

a) Coordinate with onsite and cross functional teams across different geographical locations on project activities (onsite – offshore model).

b) Improve team efficiency by identifying, resolving business issues & conflicts by conducting brainstorming sessions with cross-functional teams.