Simmy Aneena Jacob, Pmp®,Psm1 Email and Phone Number

Perform project management and portfolio management in the financial department for pharmaceutical assignments. Also, manage projects in SAP landscape and Platform Systems. Budget management for the projects as well as the Technical Enhancement Requests at portfolio level.• Manage SAP Infrastructure migration, Onboarding of new pharmaceutical customers for AbbVie, Development of Finance applications for business.• Support multiple teams at portfolio level to make sure the project and financial management is done effectively and prepare monthly status report for all projects in Finance department for portfolio level presentation.• Work with BTS leads for defining Capital Plan and Long-Range Plan projects.• Day-to-day management of the project, including creation & management of key project deliverables, managing risks and issues including mitigation strategies to remove roadblocks, budget management, collaborating across program stakeholders and work with executive sponsors to drive these deliverables and project to completion.• Perform Budget Management for the project which includes setup, monitoring of progress against contract, expenses, invoices, reconciliation, and tracking in Jira and SAP.• Work with SQA Team for the SLC process related to GXP, SOX regulated applications.• Determine project goals and priorities with Steering Committee which includes Business and IT Leadership, project sponsors, and other key stakeholders.• Collaborate with all project stakeholders to proactively identify and mitigate project risks with frequent reevaluation and reprioritization of the risk register.• Proactively prepares/presents project financial information and recommendations to stakeholders to ensure financial success of the project.• Support with onboarding of new project team members and project managers.• Work with Continuous improvement team to revise the procedures, add new features to the Project Management tool.

Manage new product development for Medical Device software. This includes the execution of full software development life cycle of public-facing Web and Mobile products, including project management, project planning, scope, feasibilities, timelines, high level impact assessment & effort estimate, stakeholder identification and communications, progress updates, and quality deliverables. Generate status reports, risk assessments, issues, and CRs in the Quality Management System. • Perform high-level impact assessment/feasibility study and create business case, for scope management with Product Owner, Commercial team, Regulatory Affairs, and Clinical Affairs.• Collaborate with Labeling, Regulatory Affairs, Information Security, Quality , Compliance and Legal & Privacy for impact assessments. • Work with Product Owners, UX-Leads, Content Writers, and labeling team for the design of the UI of the internet facing applications.• Coordinate, and Perform check ins for; initial drafting of scope, requirement specification finalization and handover, development check points, development handover, UAT handover, Client Demo, and Lessons Learned.• Collaborate with Production education and Customer Service team to ensure the successful completion of training for Customer support.• Collaborate with the Regulatory Affairs team to ensure global regulatory compliance of products.• Perform regular assessment on the progress of the project to make sure the project is on track.• Produce weekly project forecast to ensure defined scope is delivered and managed to timelines and budget; Communicate project status to management and project stake holders. • Update the project dashboard and present the status in Portfolio meeting.• Make sure the smooth handover of the application to the support team after hyper care and ensure the successful closure of the project.

Execute full software development life cycle of essential pharmaceutical assignments in Clinical trials, including project management, change management, problem management, incident management, project planning, scope, feasibilities, timelines, high level impact assessment & effort estimate, stakeholder identification and communications, progress updates, and quality deliverables. Generate status reports, risk assessments, issues, and CRs in the project management/ITIL tool. Perform roles of Project Manager, Change Manager, Technical Assurance Analyst and SDLC SME for GxP and non-GxP applications. • Review SDLC deliverables and coordinate Business, Technical and Quality Signoff. Prioritize and delegate personnel tasks and assignments. Apply best practices to project operations and adhere to established budgetary guidelines. • Manage the on-going support and maintenance of the clinical applications.• Perform high-level impact assessment/feasibility study and support business team to formulate business case, as part of scope management.• Conduct the kickoff meeting, prepare project plan, perform high-level effort estimate for schedule management.• Work with SQA and Quality Representative for the review of SLC documentation including Change Controls, Design Specifications, IQOQs and for the projects related to GxP/non-GxP applications.• Support application migration from legacy infrastructure to AWS.• Perform regular assessment on the progress of the project to make sure the project is on track.• Work with project stakeholders to review the impact assessments performed. • Guide the project team during the entire SDLC of the project. Meet with stakeholders regularly for the successful execution of the project. • Produce weekly project forecast to ensure defined scope is delivered and managed to timelines and budget; Communicate project status to management and project stake holders. • Support GxP and non-GxP changes related to multiple functional areas.

Execute full software development life cycle of essential Pharmaceutical assignments, including change and project management, project planning, scope, change assessment, feasibilities, timelines, stakeholder communications, progress updates, and quality deliverables.Manages and ensures projects include GxP/non-GxP changes are executed efficiently and effectively. Manage the governance of the life cycle of changes and make sure that only authorized changes are implemented.Review CRs in the ITSM tool. Review SDLC deliverables and coordinate approver Signoff. • Support GxP and non-GxP changes related to multiple functional areas.• Guide the team in the entire change cycle for SDLC deliverables. Meet with stakeholders regularly for the successful execution of the changes.• Meet with the required stakeholders to achieve the robust management and successful execution of the change requests from planning till closure and also for continuous improvement. Record and publish the meeting minutes. • Serve as SME for Change management specific activities. Review the Change Management reports/scorecard for schedule adherence.• Review the Change Plan which includes Impact assessment , confirms test and implementation plans are available and meet the policy and procedure requirements.• Review the Change Request submitted for Implementation to ensure it is accurate and complete. Confirm that all the identified tasks, including deliverables and testing, have been completed per plan.• Confirm that evidence, recorded in the change record, is available to support the implementation activities that were performed.• Participate in compliance forums on change management and ensure robust understanding of process and discuss opportunity for continuous improvement.• Manage the assessments, implementation, approval and closure of the changes based on policies, procedures, standards and quality requirements. Engage the CAB as required.