Manager Software

K a rteek R Sandadi

Phone: 973-***-****

Email: Kar ****.*.*******@*****.***

P rofessional consultant with strong analytical and problem solving capabilities. Excellent

communication and interpersonal skills. Extensive knowledge and working experience in areas of:

•

• • •

Program Global Deployment Regulatory Systems

M anagement of Enterprise Submission and I n tegration

Systems Publishing

• •

Document Validation • Consulting

M anagement

Systems

PROFESSIONAL SUM MARY:

• Professional consultant in the Health care industry with experience in managing

h ighly technical and diverse teams within all aspects of the solution deployment.

• Proven ability to communicate effectively with all levels of management. Experience

i n developing and driving the execution of programs, methodologies (software

development lifecycle), processes (business process design and requirements

gathering workshops), project planning, t raining, decision making, and meeting

p roject deliverables with the highest quality on a t imely manner.

• Ex tensive experience with implementing highly technical enterprise systems i n both

i nformatics and regulatory areas. This includes document management,

collaboration and publishing systems for regulatory submissions f rom design review

to production.

• Subject matter expert with filing drug applications in electronic and paper format

g lobally. Recognized industry-wide as a key member in developing regulatory

submission processes for the pharmaceutical industry.

• Extensive experience working with IT resources to ensure effective and sustainable

deliverables including solution architecture, system requirements, functional

specification, configuration specification, data migration, and including testing.

• Experience in developing standards and processes to provide validation solutions

across multiple regulated software applications which includes development of

master test plan, master validation plan, functional requirement specifications,

user-requirement specifications, validation summary report and t raceability mat rix,

p rotocol variance reports and protocol deviation reports.

Work H istory

Associate Manager, Software Operations Dec

2010 – Present

CSC-RSG Group

• Manage all Pfizer informatics and regulatory projects on behalf of CSC. Tasks

i nclude leading the Pfizer – Wyeth merger, assisted in consolidating regulatory

p ublishing tools, document management systems, docbase migrations into a single

point system. Assisted in defining the business process, regulatory publishing and

regulatory strategy during the integration.

• Manage all Abbott regulatory projects on behalf of CSC. Tasks include leading the

deployment of regulatory publishing systems, configuration and data-migration

g lobally.

• Manage all AstraZeneca regulatory publishing systems implementation projects.

• Manage Hospira regulatory projects on behalf of CSC. Tasks include data-M igration

f rom third party regulatory publishing tool into CSC eCTDXPress. Working with

business users globally to resolve issues encountered during migration.

• Member of research group at CSC responsible for building cloud computing

regulatory t racking solution systems.

• Responsible for the technical consulting team’s execution and delivery of services in

client engagements. Oversee logistical, operational and administrative functions.

• Directed consulting services for all clients, covering business process development,

regulatory consulting, technical Consulting and software Education.

• Advise clients on developing business processes to meet complex technical business

requirements across a wide variety of industries and domains .

Associate Manager, Software Operations May 2009

– Nov 2010

I mage Solutions I nc., NJ

• Manage a mid size team of 12+ Engineers that is responsible for designing and

i mplementing regulatory software systems globally.

• Successfully redefined market strategy and service methodology to capture the value

chain and develop business model for expanded long term growth.

• Trained and mentored staff to cater to industry’s standards and achieve a growing

demand for business opportunities.

• Created and implemented processes, strategies and standards with other business

u nits of the company to streamline tasks and producing sustainable products and

services.

• Authored SOWs, project plans, project schedule, defining the roles & responsibilities,

communication and r isk management plans.

• Managed projects that focused on deployment and upgrade of regulatory publishing

systems at top and mid tier pharmaceutical companies like GlaxoSmithKline,

Takeda, Hospira, Baxter, Forest, URL Pharma, Mylan and Abbott.

• Managed projects that focused on migration of eCTD submissions from one eCTD

tool to another at companies like Pfizer, Takeda, Astellas, Warner Chilcott, Vertex.

• Member of research group at ISI responsible for designing SaaS and Pre-Qualified

regulatory solution systems.

• Responsible for building the software operations team in Asia (China).

Senior Systems Engineer, Software Operations Nov

2008 – Apr 2009

I mage Solutions I nc., NJ

• Developed methodologies for proof of concept evaluations.

• Participated in onsite project kick-off meetings, collected business user

requirements, analyzed and designed architecture for system implementation.

Recommended hardware/software specification to ISI clients.

• Onsite consulting services for top and mid t ier pharmaceutical companies like

A bbott, Novartis, Élan, Johnson & Johnson, Imclone, Br istol Myers Squibbs,

Cephalon and Boehringer Ingelhei m covering requirement gathering, business

p rocess development, regulatory consulting, technical consulting and software

education. T his includes implementing systems by following client’s validation

methodology and providing technical support during the project.

• Developed submission migration strategies for migration of eCTD submissions from

one eCTD tool to another. Experienced in m igration between eCTDXPress,

docuBridge, eSS, Datafarm, Insight Publisher, eCTDManager, Pharmaready and

Octagon.

• Assisted with t raining on all ISI publishing applications.

• Worked with development team to ensure that client input/feedback were

i mplemented in future product releases.

Systems Engineer, Software Operations Sep

2007 – Sep 2008

I mage Solutions I nc., NJ

• Involved in deploying regulatory publishing systems for Watson, Ranbaxy, Abraxis,

A kros, Stryker, Santene, Idenix, Enzon and Shire. This includes designing global

system architectures, gathering system requirements, implementing various

systems by following client’s validation methodology and providing technical support

d uring the project.

• Authored deployment roadmaps, system design specifications, technical manuals,

t raining manuals, configuration guides, data f low diagrams and system requirement

documents.

• Developing and Conducting user acceptance Testing (UAT) and documentation of

test cases.

• Performed validation activities on several projects involving authoring and where

applicable execution of SOPs, validation protocols, functional requirement

specifications, user requirement specifications, installation qualification, operation

qualification and client business process qualification, master validation plan,

master test plan and summary.

• Involved in reviewing and developing computer system specifications, t raceability

mat r ices and validation documents.

EDUCAT IONAL BACKGROUND:

• Master of Sciences, Electrical Engineering, University of Missouri – Kansas City,

M issouri, USA.

• Bachelor of Engineering, B.Tech, JNTU, India

S kills

Document Management Systems:

• Documentum (4.x, 5.x and 6.x), SharePoint, FirstDoc, LiveLink, IB M Score and

NextDocs.

Database Systems:

• Oracle, MSSQL.

Terminal Servers Software:

• Cit r ix, Terminal services installation & configurations.

Vi rtual OS:

• Vir tual Servers, ESX servers 3.5 and 4.0

Publishing Software:

• eCTDXPress, docuBridge, Global Submit, Octagon, EURS IS YOURS, eSS,

eCTDManager, eCTD Gecco, I SIPublisher, Vi r tual Link Manager, ISI Submission

M anager, DocComposer, ISIToolBox, ISIWri ter, CRFTrack, ISIRender, ISIRegTracker,

I nsightPublisher, Pharmaready and CoreDossier.

Pharmaceutical Electronic Submission Formats:

• Publishing experience with eCTD, CTD, eNDA, eBLA, eIND, Study CTD and MAA.

• Working knowledge of CBER/CDER regulatory guidance, 21 CFR Part 11, CDISC

guidance, SPL/PIM, GMP, GAMP 4/5 Validation.

Testing Tools:

• Mercury Quality Center, Win Runner, Load Runner.

GU I Tools:

• MS Excel, MS Word, MS Access, MS Publisher, MS PowerPoint, MS Project,

M S Outlook, MS FrontPage, Adobe Acrobat.

OOAD Methodologies:

• Rational Unified Process (RUP), Software, Development Life Cycle (SDLC).

Web Servers:

• MS I IS, Tomcat Web Servers

R EFERENCES:

REFERENCES Available On Request

Contact this candidate