Management Director, Manager
Resume:
Page
of
Ravi
Nanjangud,
B.Eng.
(CS),
MBA
***************@*******.***
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
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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
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Ravi
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• 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