Contact Information

Anoop Ramakrishnan

Gaithersburg,MD,USA.

Phone: +1-908-***-****

Email: acg9mr@r.postjobfree.com

Professional Summary

. 8 years of experience in the field of Information Technology and Life

science domain

. Good experience in handling Global Support Model .

. Experience in leading Global R&D support on the Regulatory portfolio.

. Strong consulting experience on Pharmaceutical and Regulatory domain.

. Good experience in Content Management Systems using Documentum 5i

tools like Desktop Client, Documentum Application Builder, Workflow

Manager, DFC, DQL, WDK, Business Process Manager/Services (BPM/BPS),

WebTop, WebPublisher, Documentum Administrator and Java Method Server

. Good knowledge on D6.7 and D6.5 products of Content Server 6.7/6.5,

WebTop 6.7/6.5, DA 6.7/6.5,Document Transformation Services (DTS) 6.5,

Workflow Manager 6.5, Process Builder 6.7/6.5, Process Integrator

6.7/6.5, TaskSpace 6.5, Composer 6.5 and DQL.

. Experience in Installation & Configuration of Documentum Content

Server 6.7,6.5 and 5.3, Documentum Webtop, Documentum Administrator.

. Experience in UNIX environment with documentum content server 6.6,6.7

and Index server administartion.

. Sound knowledge on the rendition server administartion(Liquent

Enterprise Services 3.15 and Liquent Core dossier)

. Experience on VMware vSphere Client 5.1.0 for managing VMware Servers

and experience on DameWare Version 6 for managing Liquent Coredossier

generators.

. Good experience in CSC FirstDoc 6.4,6.3,6.2.1 and 4.2 on the platform

level.

. Experience in the pharma domain and have experience in regulatory

submissions.

. Good experience on Liquent Insight publisher 4.7,5.0 and worked on US

and EU regulatory submissions.

. Good experience on regulatory submission validations using Insight

Validator 5.0,Extedo EURSValidator 3.0,GLOBAL Validator 3.0 and

Lorenz eValidator 5.2

. Good experience on eCTDViewer WebEdition 4.1.3, Global Submit Validate

5.1.0, Datafarm VUE 1.2.

. Experience on Liquent Insight for Viewing 5.0 (also legacy WebViewer

4.1.3) for eCTD viewing

. Experience on Adobe plug-ins like Liquent SmartDesk for PDF 4.0,

Liquent Smartlink 1.4and CSC's ISIToolBox 6.2 for dossier publishing

. Experience on Liquent S-Cubed Publisher 4.5.3 for the creation of

eCTD and paper submissions for both US and EU region.

. Exposure in Requirement Analysis, Application Maintenance, Functional

Studies, Quality Reviews and Testing.

. Participated in implementation of change controls in highly regulated

Test/production systems.

. Authored and reviewed IQ documents including ISD (Installation support

document), IQSW (Installation Qualification of software and hardware

components) and various change control documentation for validated

systems.

. Sound knowledge on IBM Websphere Portal server 6.1, have worked on

Filenet development with IBM Websphere as server, spring framework and

IBM RAD for development and implementation.

Sound knowledge and expertise on the following area:

. JAVA experience on JDK 1.6.

. Documentum 6.7,6.6,6.5 and 5.3 development and maintenance on the

platform level(including server administraton).

. FirstDoc 6.4,6.3,6.2 and 4.2 development and maintenance on the platform

level(including server administraton).

. Regulatory submission experience on Liquent Insight Publisher 4.7,5.0 in

platform level(front end and back end).

. Good expereice on Liquent Enterprise Services 3.1.5(rendition services)

administration and configurations.

. Good experience on managing Liquent Coredossier Generators(Rendition

Services)

. Good experience on S-Cubed Publisher 4.5.3, Liquent Insight for Viewing

5.0, legacy WebViewer 4.1.3,

Insight Validator 5.0,Liquent eCTD Reviewer 1.4.1.50,Liquent Smartlink

1.4,Global SubmitValidator 5.1.0, Global Submit review 4.2.1,Extedo's

Validation tools - Extedo EURSValidator 3.0,GLOBAL Validator 3.0,Lorenz

eValidator 5.2 and CSC's ISI Toolbox 6.2

Education

. Bachelor of Engineering in Computer Science and Engineering (SSM

College of Engineering,Anna university Chennai,India,April 2007,80%

Aggregate).

. Diploma in Computer Engineering (Govt Polytechnic College Pala,

Kottayam,Board of Technical Education, Kerala,India,May 2004,84%

Aggregate).

Certifications

. EMC Content Management Foundations(EMC E20-120)

. Sun Certified JAVA Professional

Technical Expertise

Operating Systems Windows,UNIX,LINUX

Virtual Machine VmWare 5.5, 6.0, VMware vSphere Client 5.1.0,DameWare Version 6.

Languages/Technolo C,C++,VisualBasic,C#,Java1.6,JavaScript,HTML,VBScript,XML,JSP,Se

gy rvlets,Struts,Web Services,RMI.

Content Management Documentum 6.7/6.6/6.5/5.3,Documentum Administrator

5.3,6.5,6.6,6.7, Application Builder, DFS, Desktop Client, WDK,

WebTop 5.3,6.5,6.6,6.7,Workflow Manager 6.5, DQL,BPM, BPS,

Documentum Transformation Services 6.5,Application Builder,Forms

Builder 6.5,Web Publisher 6.5,eRoom,Process Builder 6.5,Process

Integrator,D 6.5 Composer,TaskSpace 6.5,ADTS 6.5, DFC 6.5,CSC

FirstDoc 6.4,6.3,6.2, 4.2,FirstDoc SPX,Rendition

Services(Liquent Enterprise Services 3.15 and Liquent Core

dossier)

Database & Tools Oracle,SQL Server,IBM DB2

Web/Application Websphere 6.0,Apache Tomcat 6.0.37, JBOSS, Internet Information

Servers Server (IIS).

Other Technology Eclipse IDE 3.5.2,IBM RAD

Skills

Regulatory Liquent's submission management Tools ( Insight Publisher

Submission Tools 4,7,5.0,Insight Validator 5.0,4.1,Liquent eCTD Reviewer

1.4.1.50, Liquent Smartlink 1.4,Liquent Subed publisher

5.0,Liquent Coredossier),CSC's- ISI ToolBox 6.2,Global

SubmitValidator 5.1.0, Global Submit review 4.2.1,Extedo's

Validation tools - Extedo EURSValidator 3.0,GLOBAL Validator

3.0,Lorenz eValidator 5.2,i4i ALice.

Professional Experience

Aug 2013 to Till Date

Title Otsuka Regulatory Support and

Maintenance

Client Otsuka America Pharmasuetical Inc.

Tools Documentum Content Server 6.7,

Documentum Administrator 6.7, WebTop

6.7,DFC 6.7, FirstDoc 6.4, EMC

Documentum xPlore Index Server, Insight

Publisher 4,7,5.0,Global SubmitValidate

2010, Global Submit Review 2010,Liquent

eCTD Reviewer 1.4.1.5, Adobe Plug-ins

including ISI ToolBox 6.2 and Liquent

Smartlink 1.4,Extedo EURSValidator

3.0,Lorenz eValidator 5.2,

VBScript,XML,Apache Tomcat,

JBOSS,Windows Server 2008, Internet

Information Server (IIS),Microsoft

Sharepoint 2010,,Liquent Enterprise

Services 3.15(Rendiion Services),Oracle

11 g, CSC FirstDoc SharePoint

eXperience (SPX), EMC Information

Rights Management (IRM) Server, EMC PDF

Annotation Services, Liquent Cumulative

View Builder, Liquent PDF Aqua,

Wingspan Docway,Adobe Acrobat 9.0,i4i

Alice.

Team Size 10

Role System Analyst/Onsite Support Team

Member-Regulatory Submissions

Location Rockville,Maryland

Project Objective

The goal is to provide global support for the R&D department for Otsuka

America Pharmaseuticals Inc.GEPIC support is a global program which have

applications globally which includes applications concerning regulatory

submissions.

Project Description

The Regulatory Support team facilitates the operation and maintenance of

the GEPIC system (Firstdoc and Doumentum based), Liquent Insight Publisher

and Liquent Insight Registration Planning and Tracking Module (ORIOM

System).GEPIC is a content management system which acts as a repository to

maintain submission-related content and metadata from various departments

in Otsuka, including, but not limited to, Clinical, Nonclinical, Quality

(CMC), Regulatory, and Safety.

Insight Publisher is used to publish all Clinical Study reports and eCTD

paper and electronic submissions to various agencies including FDA, EMEA

and HC etc.ORIOM system is used to centrally collect, manage, and track

worldwide product authorizations and registrations of Otsuka

Pharmaceuticals.Global Submit Review is using for reviewing the submissions

and QC checks. Global Submit Validate is using for validating the

submissions before it is being prepare for sending it to the agency.

Electronic submissions Gateway is being used to send the submissions to the

agency.We use Liquent Insight Publisher 4.7 for building the submissions

for US and EU region. We use Liquent Enterprise service 3.1.5 for both

publishing and rendition services and provide platform support for Liquent

Enterprise services.Project is mainly intended for giving platform support

and help the publisher's for building the submissions through Liquent

Tool's such as Insight Publisher 5.0 and also helping them to validate the

submissions through validations tools such as Global SubmitValidator 5.1.0,

Global Submit review 4.2.1,Extedo's Validation tools - Extedo EURSValidator

3.0,GLOBAL Validator 3.0 and Lorenz eValidator 5.2.We use i4i Alice sytem

for labeling submissions.

Otsuka use CSC's Firstdoc 6.4 for document management system and EMC's

documentum 6.7 as repository.We provide platform support/maintenance and

enhancement to the document management system's.The project involves the

support for on one of the critical NDA regulatory submission of the company

and involves the support for all regulatory submissions.

Role and Responsibilities

. Directly interact with Business on new requirements and implement it

through Change control process.

. Directly interacting with end users to resolve issues in GEPIC and

submission tool's.

. Work with vendor's such as CSC and Liquent for any product related

issues.

. Platform support for Liquent's Insight publisher 4.7/5.0 and all US

and EU submissions..

. Provide platform technical support for Documentum 6.7/ CSC FirstDoc

6.4 document management systems.

. Directly work with publishers to identify any issue with submissions

and help them to validate it.

. Identify any changes according to business needs and implement on the

production platform for submission tools and document management

system.

. Monitor all production servers and work on the maintenance activities.

. Configuration of Documentum ContentServer, Documentum Webtop, and

Documentum administrator.

. Provide platform support for Liquent Enterprise Services 3.1.5 for

publishing and rendition services.

. Supporting Liquent Insight for Viewing 5.0 (also legacy WebViewer

4.1.3) for eCTD viewing

. Supporting Adobe plug-ins like Liquent Smartlink 1,4 and CSC's

ISIToolBox 6.2 for dossier publishing.

. Supporting eCTDViewer WebEdition 4.1.3, Global Submit Validate 4.1.3,

Global SubmitValidator 5.1.0, Global Submit review 4.2.1,Extedo's

Validation tools - Extedo EURSValidator 3.0,GLOBAL Validator 3.0 and

Lorenz eValidator 5.2

. Participated in implementation of change controls in highly regulated

Test/production systems.

Contact this candidate