Srinivas Kotha Email & Phone Number

Princeton, Nj

Delivered several solutions across all functional areas, including Regulatory, Labeling, Clinical Management, Clinical Data Management, Pharmacovigilance, Non-Clinical, and CMC enhancing operational effectiveness related to content management and publishing systems, authoring tools, and Regulatory Information Management Systems (RIMS). As a subject matter expert in Global Regulatory Affairs. Collaborated with Regulatory Affairs Managers, Regulatory Affairs Publishers, and Otsuka IT staff to achieve the best results regarding publishing. Eliminated the use of language/region-based authoring template deployments by designing solutions that utilized a single authoring template using Litera's DocXTools, bringing about significant cost savings in development and maintenance. • Achieved a 10-15% acceleration in publishing time and a 10% reduction in publishing errors by devising and implementing new content management and publishing solutions, utilizing Documentum/CARA and Lorenz docuBridge systems.• Orchestrated technical support in developing a solution that cut down the authoring and reviewing of documents by at least a week using PleaseReview as a collaborative authoring/reviewing tool. • Developed solutions that reduced the effort in maintaining authoring templates by 50% by designing a system for authors to use and maintain authoring templates within the content management platform (Documentum/CARA). • Led and designed the migration initiative to transition Otsuka's Documentum platform from FCG's FirstDoc to Generis CARA application.

Fort Washington, Pennsylvania, United States

Led the design and implementation of Documentum's D2 system at McNeil Consumer Healthcare. Spearheaded the upgrade and migration from DCM to D2 in collaboration with teams from Quality (validation), infrastructure (server deployments), database (Oracle), and vendor (EMC Documentum). Directed the team in the development of new modules for use in the Manufacturing Execution System (MES), Labeling, and Quality Assurance groups while acting as technical lead and system architect for the content management platform (Documentum DCM and Documentum D2). • Developed and implemented innovative content management solutions as an IT consultant for the Quality team and other IT infrastructure groups during McNeil's consent decree period.• Ensured a smooth transition from DCM to D2 while leading the implementation of Documentum's D2 system facilitating collaboration between various teams to ensure a successful upgrade and migration process.• Leveraged technical expertise to architect the content management platform (Documentum DCM and Documentum D2) at McNeil Consumer Products Group.

Upgrade EMC Documentum suite of products to 6.5 sp2. Experienced in Content Server, Web Publisher, SCS/SDS, IDSx

Client – Biogen-IDECArchitected the upgrade/migration of Biogen-IDEC’s Documentum installation – Biogen Regulatory Affairs Submission System (BRASS) from 4.2.8 (HP-UNIX) to 5.3, SP2 within the Regulatory Affairs Informatics Group.Client – Alexion PharmaceuticalsArchitected the upgrade/migration of Alexion’s Documentum Infrastructure from 5.2 to 5.3, SP1 in Windows/Microsoft SQL Server environmentInstalled and configured Apache Tomcat application server, Documentum Administrator and Documentum Webtop on the Apache Tomcat platformInstalled and configured Documentum Transformation Services (DTS) and Documentum Annotation Services

• Define, socialize and communicate the architecture for Pharmaceutical Research Institute (PRI) content management applications• Lead multiple working groups of Informatics members to collectively define the present and future state of content management applications and systems for the PRI• Technical Architect for the EPIC STAR (Compliance Document Repository) - a system for managing Standard Operating Polices and Procedures (SOPs) and Quality System Documentation (QSDs) using Documentum’s Documentum Compliance Manager (DCM) product • Technical Architect for the PURL (Persistent URL) project for maintaining links for documents within documents and websites• Involved in a pilot study to import/integrate training documentation into Plateau’s eLearning System• Designed/Architected a solution for migrating content from legacy content management systems to the PRISM repository (submissions management system)• Define preferred hardware and software architecture for content management working with the Global Shared Services group, various Application Development groups, Search Architecture group and other members of Informatics organizations• Define an Informatics wide recommended, repeatable upgrade strategy for Documentum and other related content management software• Maintain and grow relationships with key Informatics members to analyze and make recommendations on content management synergies

• Technical Architect/Technical Project Manager for the Data to Documents (D2D) application – This is a web application to import ASCII files (SAS data sets, etc.) into a Documentum repository (PRISM - a Regulatory submission management system) and auto convert to MS Word documents. Application was designed and built with various Web Services that are now being used by other groups for importing content into Documentum repositories, viewing content from various repositories, applying watermarks based on business rules for each individual group, etc.• Manage and lead members of the Technical Team - Documentum Administrators and Developers to achieve set objectives in delivering content management applications across the globe• Technical Architect for the eXplore Search Interface. This system provided a mechanism for searching various Documentum repositories from a single web interface based on a common dictionary values set in the background. This was later converted to a Web Service which enabled other systems to issue a call and get results back as a XML data set• Member of the PhRMA eCTD (electronic Common Technical Document) Working Group representing Bristol Myers Squibb Co. This group is responsible for establishing the new XML based submission guidelines for the Pharmaceutical industry for electronic submissions

• Technical Architect for the PRISM 2.0 (DocConfigurator/CARA) System. System was upgraded from 4.1.x version of Desktop Client to a custom interface with workflow using Visual Basic • Manage, Deploy and Implement the PRISM 1.0 (using First Consulting Group’s RDSO) System for managing the Regulatory Submissions Documents• Implemented a Scanning/Publishing solution (using InputAccel) for the PRISM 1.0 system to scan Regulatory Submission Documents• Implemented a Scanning/Publishing solution (using InputAccel) for simple publishing of non-submission documents using the CDC Solutions PDF Transformation products along with Documentum

Manager Internet/Intranet Applications• Managed the members of the Internet/Intranet and Documentum Applications team• Architected, developed and deployed Documentum Applications globally• Architected, developed and deployed Internet/Intranet Applications• Member of e-Business strategy team for the West Pharmaceutical Services Inc.Systems Analyst – Documentum• Installed and configured Documentum software on Windows NT and MS-SQL servers• Customized Documentum's SOP DocSolution and DocControl Manager software• Installed, configured and customized CADLink Pro software to Documentum and AutoCAD• Developed customized applications for corporate Intranet using HTML, Docbasic and JavaScript• Developed user guides and trained users on how to use Documentum and related productsCAD Systems Engineer• Maintained CAD Systems in two divisions (Lionville, PA and Montgomery, PA facilities) of the West Company• Customized AutoCAD as required by the Design Engineering department• Wrote programs in C and C++ using Autodesk’s ADS and ARX Programming API for AutoCAD• Wrote/maintained programs and procedures to run the tooling database• The work I did as CAD Systems Engineer resulted in me getting a promotion to the Information Systems group as a Documentum Systems AnalystTooling Engineer, Manufacturing Liaison• Primarily responsible for production tooling that has been engineered and accepted into production• Reviewed material specification requirements for the production tools• Investigated new materials, and recommend new and modified methods/materials to improve quality and profitability in the division• Checked and approved product drawings, mold and die drawings for the rubber compression molded products and injection precision molded products

• Designed and developed personal safety protection equipment like spectacles, goggles, and hearing protection equipment• Oversaw the design from prototype through qualification testing. Developed and documented design verification tests• Coordinated design reviews/developments and production schedules with manufacturing, marketing and sales to meet customer specifications/requirements• Developed in-house assembly procedures and performed on-line production troubleshooting

Msme, Mechanical Engineering

Master of Science in Mechanical Engineering

Be, Mechanical Engineering

Bachelor of Engineering