Page

*

of

*

Ravi

Nanjangud,

B.Eng.

(CS),

MBA

707-***-****

acr2jj@r.postjobfree.com

3

Abbott

Lane

#5

Concord,

MA

***** ********

Highlights Functional

/

Domain

Expertise

• Result

driven

leader

driving

organizations

achieve operational

excellence

through

collaboration

and engineering

innovative

sustainable

integrated

solutions

• 17+

years

building,

leading,

mentoring

&

motivating

teams to

develop

&

execute

strategies

for

business

growth leveraging

technology

• People

Management

o Strong

people

manager

with

emphasis

on transparency,

collaboration

&

ongoing

development

o Led

distributed

staff

of

70+

direct

and

indirect reports

to

establish

strong

High

Performing

teams

• Innovation,

Business

and

Cost

Management o Excellent

Business

relationship

management experience

o Define

and

establish

Governance

structure o Solutions

designed

and

delivered

within

budget o Managed

budgets

<=

$

5M

• Defining

and

Executing

Business

aligned

IT

strategy o Define

and

execute

short- term

and

multi- year

IT Road

Maps

o Excellent

strategic

planning,

leadership

and technology

implementation

skills

o Excellent

information,

program

and

change

mgmt. skills

associated

with

technology

innovations o Ability

to

quickly

assess

new

technologies

and products

needed

to

address

critical

business needs.

• Strategic

and

Tactical

Solution

Delivery o Define

and

Execute

strategies

to

balance

In- sourcing

vs.

Out- Sourcing

• SME

Pharma

and

Medical

Device

R&D,

Pre

and

Post

Market Enterprise

technology,

Applications

and

Operations

• R&D,

Clinical,

Quality,

Regulatory,

Commercial

(Sales

and Marketing)

Operations

• IND,

NDA,

eCTD

submissions

• Computer

System

Validation,

SDLC,

Agile

• Audit

&

Regulatory

Compliance

(SOX,

21

CFR

Part

11,

HIPAA, HL7,

NIST- 800,

FIPS- 140,

ICH,

GxP,

ITIL,

COBIT

etc.) Software

Expertise

• SME- Oracle

Enterprise

Suite

(Health

Sci/ERP,

Agile

PLM,

EDC, Argus,

Siebel

CRM/CTMS,

AECM,

AERS),

SAP,

EDMS, Trackwise,

Salesforce,

ePRO,

eTMF,

eCTD

• Open

Source

Technologies,

Fusion,

Apache,

Web

Logic, Tomcat,

Servlets,

JSP

• Database:

Oracle,

MySQL

with

TOAD,

SQL*Developer,

Apex

• Business

Intelligence,

OBIEE,

BOXI,

&

Spotfire

• Web

Services,

SOA,

J2EE,

.NET,

ETL,

XML

• SharePoint,

MS

Word,

Excel,

Visio,

Project

and

PowerPoint

• Infrastructure

Routers,

Load

balancers,

TCP/IP

networking, HTTP,

SMTP,

proxies

and

firewalls,

SNMP,

DNS,

Cloud,

VPN, Active

Directory,

Mobile

computing,

• Unix,

Windows,

Linux,

Windows,

VMware

SAN

/

NAS Other

Areas

of

Expertise:

15+

full

lifecycle

implementation

from

ideation

to

business

case development,

implementation,

adoption

to

retirement IT

solution

design

&

delivery

Merger

&

Acquisition,

Integration

and

Divesture Process

and

Program

Management

Regulatory

Compliance,

Quality

Systems

Management Governance

Model

Risk

Management

and

Vendor

Management Emerging

Technologies:

Mobile,

Big

Data

and

Web

Applications Professional

Summary

2014

2015 Cubist

Pharmaceuticals

/

Merck,

Lexington,

Massachusetts Associate

Director,

GPV

&

Medical

Risk

Management

Projects

and

Systems 2011

2014 i- Quest,

Santa

Rosa,

California Co- founder,

CTO,

Director

&

Senior

Advisor

to

GE

Healthcare

IT 2005

2011 Medtronic,

Inc.,

Santa

Rosa,

California Sr.

Manager,

Medical

&

Regulatory

Affairs

Systems

(Biostatics,

Data

Management,

Safety,

Quality,

Regulatory) 1997

–

2005 Pfizer,

Inc.,

Groton,

Connecticut Global

Application

Lead,

Solution

Architect

Clinical

&

Regulatory

Affairs

Systems 1992

–

1997 Horizon

Companies,

Edison,

NJ

&

Value

Software,

Bangalore,

India Product

Manager,

Sr.

Analyst

Clients

included

Ernst

&

Young,

AT&T,

AT&T

Capital

Corp,

Sun

Alliance, Emirates

Insurance

Company,

Siemens

Education

Executive

MBA:

Sonoma

State

University,

California Bachelor

of

Engineering:

Emphasis

–

Computer

Science,

Mysore

University,

India Page

2

of

4

Ravi

Nanjangud Page

2

Certifications/Training

• Provisional

patent

holder

• Training

in

Project

Management,

Worcester

Polytechnic

Institute

(WPI)

• Diverse

leadership

&

management

trainings

• ITILv3

training

and

certification

• Oracle

Certified

Professional

• Guest

professor

on

IT

Strategic

Management

for

MBA

Program,

Sonoma

State

University

• Guest

presenter

at

Oracle

User

Group

Conference,

Vancouver,

Canada Professional

Detail

Cubist

Pharmaceuticals

/

Merck,

Lexington,

MA Associate

Director,

GPV

and

Medical

Risk

Management,

Projects

&

Systems

(Clinical,

PV,

Reg,

Quality

&

IT) 7/2014

–

6/2015 Led in formulating and

managing transformation program to scale and achieve global operational efficiencies in line

with the recent

FDA’s

approval

to

commercialize

2

clinically

proven

products

and

supporting

3

other

commercial

products.

• The

transformation

program

focused

on

people,

process

and

technology

spanning

internal

organizations

of

Medical

Affairs, Safety/Pharmacovigilance,

IT,

Regulatory,

Commercial

and

Quality,

to

include

their

respective

external

partners.

• Established

effective

governance

structure

to

align

business

and

IT

management

&

teams

to

ensure

business

priorities

are met,

IT

application

architectures

are

understood,

properly

implemented

and

delivered

for

adoption.

• Defined

strategic

direction,

standards,

methodologies,

tools,

priorities,

and

approaches

for

the

overall

Clinical,

Drug

safety and

Regulatory

application

architecture.

• Strategized

and led in consolidating

data,

business

process to

establish

a

unified

validated solution (spanning

business application development, testing, support and operations) and streamlining business process operations / regulatory submissions

resulting

in

cost

savings

in

excess

of

$1

million+.

• Established enterprise validated Argus Insight BI Analytic and data warehouse platform. Led development teams in establishing

a

single

source

scalable

solution

for

aggregating

by

consolidating

and

integrating

internal

and

external

data.

• Initiated

Big- data

as

POC

within

the

realm

of

Safety/Pharmacovigilance,

Medical

Affairs,

Commercial

and

R&D.

• Ensured

business strategies

and technology strategies

were

aligned.

Organized, lead,

and contributed to selection

and

of technologies

on

an

enterprise

basis

and

trained

staff

on

optimal

use

of

technologies.

• Harmonized

business

process

and

systems

across

cross- functional

teams

of

clinical,

pharmacovigilance,

regulatory,

quality, marketing

and

IT

functions

in

support

of

clinical

development

and

commercialization,

resulting

from

2

acquisitions.

• Managed vendors, standardized development of statements of work, contracts, managed service and service level agreements

with

vendors,

in

liaison

with

other

business

users

as

needed,

resulting

in

cost

savings

in

excess

of

$500K.

• Defined internal standards for vendor selection process and technology evaluation process. Directed, participated and conducted

vendor/site

audits

to

track,

measure,

&

evaluate

performance

to

ensure

corporate

and

regulatory

compliance.

• Implemented change management & had oversight of global support across internal, Vendor & CRO operations in support

of

(N- tier)

level

1

- 5

for

the

enterprise

system

based

on

ITIL

methodology,

across

onshore

and

offshore

staff. i- Quest,

Santa

Rosa,

CA

Co- Founder,

Senior

Advisor

GE

Healthcare

IT 2/2012

–

6/2014 Directed GE Healthcare IT executives in formulating, initiating and

managing transformation programs related to introduction of integrated enterprise solutions for Pre and Post

Market products. Scope of transformation encompasses R&D, Clinical, Quality Management

and

Regulatory

organization.

Conducting

GAP

analysis,

to

assess

existing

functional

processes

and

underlying

systems for

implementing

an

integrated

enterprise

solution,

it’s

adoption

with

necessary

Business

Process

Re- engineering. The

solution

scope

spanned

reviewing

organizational

structure,

functional

processes,

procedure

and

systems

in

place.

• Liaised

with

executive

management

and

internal

customers

to

prioritize

solution

delivery

encompassing

budgets,

time- lines,

and

priorities

for

IT

Applications

projects.

• Collaborated

with Functional organizations to align IT strategy and solution delivery to reduce Total Turnaround Time

(TAT) from

months to

days, in regulatory reporting for

Adverse Events (AE’s), Serious

Adverse Events (SAE’s) related to Products

within

an

integrated

solution

environment

across

multiple

therapeutic/modalities.

• Reviewed the processes and workflow associated to Call Center Management, Product complaints, identification of Adverse

Events

(AE’s),

reporting

on

adverse

events

and

Preventive

actions

across

multiple

therapeutic/modalities. Page

3

of

4

Ravi

Nanjangud Page

3

• Implemented steps to improvise functional Quality Management Processes, Corrective and Preventive Action (CAPA) process encompassing Product Complaints and Regulatory submissions, toward reducing reporting time and achieving accurate

timely

regulatory

submission

of

Safety

data

spanning16

countries.

• Implemented

pragmatic

strategies

to

consider

for

In- sourcing

Vs.

Out- Sourcing

of

Business

Operations

spanning

both

Pre and

Post

market

products.

• Recommend

and initiated steps to take

and

achieve

organizational readiness toward

ensuring

maximum

adoption

of the new

system

in

compliance

to

FDA

regulations.

• Strategic and tactical Siebel centric, system implementation considerations, to establish an integrated platform encompassing Clinical Trial

Management System, Product Life Cycle

Management System, Supply Chain System, Quality Management

System

(Trackwise)

and

Regulatory

Reporting

System.

The integrated

platform is

to

address,

device

product lines

spanned

multiple

modalities,

marketed

and

serviced

globally.

• Recommend Data Aging and Data retention procedures to sustain data growth and effectively manage regulatory reporting

for

post- marketed

products. Medtronic

Inc.,

Santa

Rosa,

CA

Sr.

Manager,

Medical,

Regulatory

&

Commercial

Affairs

Projects

&

Systems 4/2005

–

6/2011 Recruited

to

a

newly

created

position

by

Director

(Biostatistics

and

Data

Management)

to

identify

and

develop

organizational capabilities

to

overcome

CAPA

findings

and

FDA’s

483

warning

letter

establishing

an

integrity

hold

on

marketed

products. Formulated

and

delivered

transformation

plan

by

developing

a

strategic

plan

to

implement

enterprise

systems.

Collaborated

with business

partners

of

Clinical,

Safety,

Quality,

Marketing

and

Supply

Chain/Operations,

internal

global

IT

and

external

clients

towards introduction

and

management

of

innovative

processes

and

solutions.

• Led

business

performance

improvement

efforts

by

defining

and

implementing

the

organization

model

to

achieve

through consensus

alignment

of

Business

and

IT.

• Established governance board encompassing stakeholders, executive clients and sponsors from the business and technology

teams

to

address

adoption,

escalation

and

business

ownership.

• Liaised with business unit partners and corporate executives (VP’s, Directors, Managers and functional leads) to collaborate in setting short and long term objectives and strategies. Effectively negotiated and communicated across strategy, implementation, and support with the business leaders in scoping, sizing, assessing and adopting a risk based methodology

for

effective

solution

delivery.

• Established Business- IT steering committees

with focus on

Governance,

Data, businesses processes and assess emerging technology

needs

toward

adopting

solutions

aligned

to

solving

complex

business

issues

leveraging

technology.

• Established

enterprise

BI

Analytic

platform

and introduced

analytic

tool

Spotfire in

addition

to

Business

Objects

XI

with Site

builder,

SharePoint

as the

dashboard interface.

Coached

business

and technical

users

on the industry

best

practices spanning

procedures

and

processes

to

maximize

adoption

and

usage

value

from

Spotfire.

• Focused on eliminating data redundancy and designed an innovative solution to harmonize, synchronize and reuse Master

Data

aligned

with

product

Sales

Force

CRM,

SAP

supply

chain

and

clinical

CRM.

• Directed,

managed

and

delivered successfully the

multi- year

$5+

million

Oracle Life

Sciences

Suite (CDMS,

CRM/CTMS, Safety,

ePRO

and

IVRS

for

Patient

Services)

implementation

program

and

achieved

a

cumulative

ROI

excess

of

$50

million over

1- 3

year

period.

• Introduced

industry’s

first

validated,

virtualized

production

environment

of

Oracle’s

Health

Sciences

platform.

• Coached QA resources on best practices, relating to ePRO, eTMF tools and processes towards achieving operational efficient

delivery.

• Assisted

in

strategizing

and

implementing

iPad

rollout

to

the

Sales

force

team,

(a

very

early

adopter

of

iPad

devices)

for product

Sales

and

Marketing.

Deployed

device

product

demonstration

and

disposition

applications

onto

iPad

and

other mobile

devices.

• Expertise in working within FDA regulated environments with proficiency in Computer Systems Validation, Electronic Records,

Electronic

Signatures,

Audit

Trails

and

Time

Stamps.

• Provided leadership in designing, and establishing an integrated platform spanning Medical Affairs, Regulatory, Commercial

and

Quality

Systems.

• Led

in

assisting

the

business

partners

reduce

the

Total

Turnaround

Time

from

45+

days

to

5

days

in

processing

Regulatory submissions

with

a

sound

support

center

spanning

L1- Call

Center,

L2- Business

Users,

L3- IT

support

&

L4- IT

Infrastructure.

• Established and assisted the process of generating, submitting, tracking and verifying submissions to global regulatory authorities across United States, Netherlands, Ireland, Japan and China within the timelines required by regulatory authorities.

• Hired

coached

and

developed

teams

toward

achieving

high

performing

teams

to

support

critical

business

functions. Page

4

of

4

Ravi

Nanjangud Page

4

• Introduced, architected and engineered, integrated computing platform for pre- market and post- marketed products a first

within

Medical

device

industry.

• Served

as

subject

matter

expert

in

engineering,

scalable

infrastructure

and

integrating

systems

leveraging

Web

Services

/ SOAP.

• Liaised and Led in managing projects including proposals to senior management, project planning and vendor negotiation/management

when

applicable.

• Strived to enforce accountability and standardize data, process and systems, spanning information consuming and delivering

organization

towards

effective

information

management,

capacity

planning

and

release

management.

• Defined and executed Business Continuity and Disaster Recovery strategy including consolidation redundancy, capacity load

balancing,

and

data

replication

• Maximized the return on IT investment/spend by adoption of asset management (software and hardware), centralized vendor

management

and

IT

procurement

(RFPs,

RFQs,

vendor

reviews,

etc.)

practices. Pfizer

Inc.,

Groton,

Connecticut

Global

Application

Lead,

Solution

Architect

for

Medical

&

Regulatory

Affairs

Systems 11/97

–

01/2005

• Led teams with increasing responsibilities within Enterprise Database, change

management, configuration

management and testing

service

organizations.

• A

Lead

DBA

in

a

team

of

40

global

DBA’s

managing

2000+

databases

running

on

UNIX,

Windows,

Linux

and

other

heterogeneous environment.

• Devised and implemented 24x7 enterprise system support strategy (Follow the Sun

model) to

manage growth and support effectively

for

Pfizer’s

conduct

of

global

clinical

trials.

• Led and participated in transformation programs that involved technology strategy, enterprise architecture, operational improvements and technology implementations (Enterprise Systems, Web based solutions, Service Oriented Architectures

(SOA), High Availability and Business Continuity) across the pharmaceutical value chain. The value chain included clinical development,

regulatory

compliance,

portfolio

and

project

management,

M&A

integration. o Established

guidelines

for

Capacity

planning

for

databases

and

the

infrastructure

specially

when

scaling

applications

to handle

500+

concurrent

users.

o Business

Continuity

and

Disaster

Recovery

Plans

for

Pfizer

R&D

including

its

Data

Center,

conducted

disaster

simulation and

data

recovery

of

the

critical

enterprise

applications

at

SUNGUARD. o Defined functional and technical product development requirements for Oracle Health Sciences Suite COTS application. Evaluated the developed product, transferred technology to Oracle and certified for release towards adoption

by

Pfizer.

o Consolidated complex heterogeneous platforms to establish a single integrated platform, resulting from merger of Warner

Lambert

($25

Billion)

and

acquisition

of

Pharmacia

($40

billion)

companies.

• Key

member

of

internal

global

team

that

developed

harmonized

the

business

process

and

deployed

IVRS

solution

for

patient services

to

serve

patients

using

Pfizer

products

in

clinical- trial

phases.

• Reduced infrastructure costs and achieved 55% savings in excess of $3 million over 1- 2 year period. Consolidated 1000+ applications

spanning

1000+

databases

into

400+

databases

in

a

shared

database

environment.

• Established

enterprise

standards

and

procedures.

Directed

the

technology

upgrade

and

maintenance

cycles,

associated

to

the database,

warehouse

&

enterprise

applications

spanning

heterogeneous

environments

of

Solaris,

HP- UX,

AIX,

VMS

and

Win2k. Value

Proposition

• Innovative leader

with strong result

driven

execution

experience in leading transformation

programs

hands- on in technology introduction, product

management, engineer integrated solutions, solution delivery, leadership/mgmt/employee training and development,

technical- functional

training,

coaching,

organization

development,

change

mgmt.,

internal

consulting.

• Excellent

program

and

project

manager. Successfully

managed

highly complex

global, cross- functional

projects,

exceeded project

goals

and

objectives,

and

met

or

came

in

under

budgetary

targets.

Focus

on

minimizing

program,

solution

and

service development

cycle

time.

Complex

vendor

and

contract

management

responsibilities.

• Exceptional

coach

and

people

manager.

Develops

employees

to

highest

potential

through

capitalization

of

strengths,

focused development

planning,

and

strategic

stretch

assignments.

Experienced

in

both

remote

and

local

people

management.

• Strong solutions focus that allows for sorting through complex information and developing concise and effective solutions rapidly.

Dedicated

to

engineering

and

delivering

world- class

cutting- edge

technologies/

solutions

with

direct

business

impact.

• Highly collaborative with proven experience working with economic buyers to identify opportunities for integration and leverage

to

meet

varied

and

evolving

business

needs.

• Comfortable

with

uncertainty,

ambiguity,

and

constant

change,

yet

able

to

set

priorities

and

execute

on

commitments.

Contact this candidate