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Click here or scroll down to respond to this candidateContact Information
Candidate's Name
Gaithersburg,MD,USA.
Phone: PHONE NUMBER AVAILABLE
Email: EMAIL AVAILABLE
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.
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