SUMMARY

• More than 18 years of corporate experience in leading successful IT projects in different fields including Pharmaceuticals, Financial, Retail and Government.
• As a Program/ Project Manager I am committed to the set goals and deliverables to execute them with commitment and dedication with in the defined timelines.
• Provide on demand expertise, Identify Best Practices and Processes, effectively.
• Use approved process, methods, templates, targeted forms and Governance etc. for an environment where tighter regulations are required

PROFESSIONAL EXPERIENCE

Confidential

Sr. Project Manager/Program Manager

Responsibilities:

• Managing the NEO IM Regulatory/Reporting initiative for Mylan and Upjohn Acquisition and Divestiture project on alignment on Day 1 Readiness
• Developing Project Plan, Timelines, Project Strategy for eSource project which is procurement of clinical data electronically and seamless technical integration with EHRs, devices and wearables, apps and non - CRF (central & analytical labs).
• Apply project management tools and Confidential SDLC methodologies to document requirements and create project deliverables.
• Lead weekly project meetings, and prepare communications and presentations providing status updates to key project stakeholders.
• Working with cross functional leads from CMC Regulatory, BT Business Parters, key business stakeholders, QA/QC to develop project timelines. Identified critical activity path, risks, cross-functional team meeting management and communication.
• Communicate regularly with Confidential leadership and business sponsors to ensure project objectives are being met and manage communications at different levels within Confidential .
• Working closely with internal and external stakeholders to ensure scope is clear and complete, enabling detailed and accurate planning and costing.
• Managing change request process, working with Business and internal teams to complete option analysis, impact assessments and manage approvals and expectations
• Working on Product Events and Registration Licenses Confidential system used for tracking and reporting global regulatory information and and Investigational drugs projects.

Confidential

Project Manager/Program Manager

Responsibilities:

• Managed migration of data centers from legacy to NGDC, implementing, deploying and/or managing application development.
• Responsible for revewing GXP documents for Mangellan AWS cloud based compute environment for research scientists.
• Manage Change. Manage Activities in Service now. Create and update changes and attends CAB meetings.
• Developed and managed project plans/timelines. Defined resource requirements and managed large and small projects from initiation to implementation.
• Working with various R&D business partners and provides them direction, guidance on IT and identifying opportunities for the development of standard methods and policies and improving the efficiency of processes.
• Responsible for mentoring and giving guidance on technical and architectural direction, methodology, design, as necessary to support project initiatives.
• Responsible for creating Risk Assesments identification Risk and mitigation, Architecture Specification, Visio diagrams, object models and other GXP documents.
• Managing multiple projects, responsible for Identifying and scheduling project deliverables, milestones and required tasks.
• Managing delivery of Infrastructure component for application and providing operational support.
• Leading the planning for DR tests and follow-up on actions and issues identified during the DR test.
• Responsible for supporting the system enhancements, Quality testing, documentation of business requirements, move to production, global rollout etc.
• Managing vendor and client relationship to ensure that service expectations are developed and met. Maintains regular contact with clients and coordinates and reports on project progress and accomplishments.
• Leading the migration of cancer Cbioportal project from AWS Cloud to Confidential SCALe Cloud infrastructure and leveraging the scale platform to host an important collaboration R and D application for Cancer Genomics and managing Magellan Platform which provides a compute environment for research scientists deployed in AWS Confidential cloud.
• Leading LIMS upgrade to new NGDC environment, helping R&D business to move projects to AWS Cloud Environment. Managing tools and vendor relationships related to technology operations.
• Managing decommissioning applications and sever projects, Data Retention, Veeva implementation, Vaccine shoppe project upgrade, Multi-Channel Management digital project and cold fusion projects in cross-functional environment.
• Responsible for communicating with both technical and non-technical staff, stakeholders, end-users, and vendors
• Experience working with offshore teams.

Confidential

Project Manager

Responsibilities:

• Leading product/utility development efforts to apply content control around table displays generated by BARDS statistical programmers for incorporation into the CSR and other documents
• Responsible for defining project scope, SDLC deliverables timelines, milestones and deliverables.
• Managing all scope changes, obtaining required approvals, stakeholder expectations, overall project communications etc.

Confidential

Project Manager

Responsibilities:

• Managed data migration/ analysis projects which involve moving data from data center to another datacenter for performance.
• Responsible for defining project scope, Puma deliverables, program timelines, milestones and deliverables.
• Lead the analysis of the electronic Trial Master File (eTMF) module which provides the structure and functionality needed to manage the creation, review, approval, and storage of TMF content. Responsible for updating and analysis of documentum metadata, taxanommies and Dictionaries
• Managed multiple projects from start to finish, managing tasks, creating dashboards, communication, and project stakeholders.
• Coordinating resources provide clear direction and timelines for deliverables, and delegate tasks across the project team.
• Managed multiple priorities to meet all objectives and deadlines.
• Managed activities including roadmap discussions to ensure collaboration related to solution evolution and system enhancements for regulatory affairs and regulatory operations processes.
• Responsible for facilitating ITS related risk discussions on a regular basis and drive documentation of risk mitigation through the use of a risk register.
• Lead planning and delivery of Integrated Application Releases with multiple applications and various stakeholder groups from the testing phases to Go Live.
• Planned and delivered the upgrade for the publishing eCTD viewing platform, XEVMPD system to support the submission of the medicinal product information to the European Medicines Agency (EMA) to ensure the adherence to the new EU module 1 regulations for Pharma and Genzyme.
• Provide support to functional areas regarding the CMDB setup, Change Control System and configurations. Support the Validation Team and Process. Authored IQ, OQ and other Validated GXP documents.
• Lead, support and coach program team members.
• Managing Business Intelligence projects for Share team.