Data Developer

************@*****.***

646-***-**** (cell)

Monroe Township, NJ 08831

Sujata Kumari

https://www.linkedin.com/in/sujata-kumari-83779217/

EDUCATION

Bachelor’s Degree in Computer Sc. & Engineering ( 4 Years )

SKILLS

10+ years of Pharmaceutical Experience

Global Functional Business Admin for Templates in eDMS System

MS Office / Visio Expert

Procedural Guides, Guidelines, Governance rules

Extraction / Export / Mentoring of data and statistics, create listings,reports,project plan & status

Resolution strategy for global issues

Coordination with business, vendors, IT units & International /Global Business Partners and Affiliates

TOOLS

eDMS & Sharing Platforms

Veeva Vault, eDMS,WebTop, WebDAV, eRoom, Sharepoint, CMU,DQL,Repoint,GBI, GeoDIS,

Remedy

ERP, BI & RDMS Tools: MS Access/ Excel, Oracle, MS SQL Server, Cognos, Business Objects Excel, VBA Expert

MS Office ( 2003, 97,2010+, O365 )

Data Discovery Tools: QlikView, Tableau, TIBCO Spotfire,JERA, SAS, SPSS,MONARCH

Ticketing Tools: BMC REMEDY IT SERVICE MANAGEMENT, Trackside, IBM Service Now

Publishing Tools: CoreDossier, Liquent Insight Publisher, eCTD

Work Experience

Client: Sanofi ( Sr. Consultant)

Duration: Feb,2005 – Present

Job Role: - Global Regulatory Template Developer and Administrator

Client: Sanofi (Sr. Consultant)

Duration: Feb,2005 – Present

Job Role: - Global Regulatory Business Analysis ( Data / Report Developer and Analyst )

Managing transformational projects and drive work stream towards major milestone achievement and covers projects stream.

Project Leader for various upgrade and process improvement efforts, working as part of a global unit providing support and insights for developing content to support business strategies

Establishes strategic partnership with other functions and business entities

Business process analytics using Excel, Visio flowcharting, activity diagrams and workflow models

Operational Cross functional business / data analysis & support, Innovative solutions to resolve issues/ automation of business process

Analyzing large data sets and created data models to have informed decisions making

Innovative Tools designed for Quality Review and Consistency Checks, Quality Improvement methods and tools, tracking & reporting

Involved in in Process improvement, Data Governance and harmonization Process

Experience with big data (SAS, SQL, etc.) and MS Office, Excel, Access, PowerPoint

Finding gaps and developed innovative tools for document /data search, extract data,gap–risk,data analysis, reports and tools development for document accuracy for Collaboration projects

Change Management – Changes, Requests, Approval, Architecture ( CMDB/ GeoDIS )

Effective at working with business partners/stake holders to understand their requirements and translate them into technical specifications, involved in many Regulatory projects, knowledge transfer to business units to ensure proper implementation

Excellent Leadership, Multitasking and communication skills, energetic, inquisitive, positive approach to problem solving

MAIN PROJECTS ( Done at Sanofi )

•Veeva Vault RIM – One Submission Platform Global Regulatory Project (Content /Template Migration, Harmonization & Governance Project )

-Project Lead for Veeva Vault RIM Template Harmonization across global system and affiliates

-VBA, Veeva Vault RIM, ServiceNow for ITSM, Sharepoint, Office 365

•Documents Submission System (eDMS Documentum ) for Regulatory Affairs

-Business Process Documents Support

-Global Regulatory Template Development and Administraror (Life Cycle Maintenance,Version Control, Application Support, Business Analysis)

-Documentum,,GeoDIS D2,BMC Remedy ITSM for change management, release management, incident management, and problem management.

•Regulatory Information DIGEST & Here-I Application–Regulatory Intelligence Digest

[RIDigest] is the application designed for Regulatory Intelligence and Information. Regulatory news analyzed and summarized by the global regulatory team is stored in the application and can be searched at any time. Authors provide feedback and information about different domains, regions, topics. RIDigest customers receive an e-mail alert that, by default, includes all regulatory news collected by the RIDigest team the previous day for the above categories.

-Global Document Administrator for Regulatory Agency Information and Details

Jan 2007 –Dec 2009 – Took Voluntary Resignation from RadPharm to take care of 2 little kids

Client: RadPharm ( Now called BioClinica )

Duration: Dec,2002 – Dec,2005

Job Role: - Data & Business Analysis ( Excel / Access )

Planned the System Design Process, Developed Data Models, and Implement and administer databases based on the data models. Build, test, install and maintain all companywide reporting applications. Development and administration of Excel-based spreadsheets used in tracking of information used in image-based clinical trials for the pharmaceutical industry. Patient /Site Specific reports and documents to support commercial operations.

Client: BusinessEdge

Duration: Jan,2002 – Dec,2002

Job Role: - Data & Business Analysis ( Excel / Access )

This system was designed to replace the current billing system and develop a reliable and fast system and to coordinate other existing systems to improve performance in management of customer usage, billing, order processing and customer services. Develop financial, billing, customer enquiry and usage report for higher management.

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