Project Manager Technical Writer

Kevin O’Keefe

Experience Highlights PAGE *

I. II. Kevin J. O’Keefe III.

*** ******* **. 732-***-****/732-539-

**** (c)

Brielle, NJ 08730

*.***********@*******.***

Relevant Experience:

In-depth background of over 15 years as a writer, technical writer, producer, director,

analyst and project manager in a variety of fields including healthcare, finance,

advertising/marketing, pharmaceuticals, television production, engineering courseware

development, and education.

Accomplished writer, producer, and communicator - experienced in rendering clear concise

deliverables from source material of varied form and origin. Extensive work in the

pharmaceutical, medical and business sectors producing informative pieces including web

content development, procedural manuals, monographs, articles, oral presentations, video

and audio programming, CDs and training modules for technical and non-technical

viewers.

Author of numerous technical documents incorporating first-hand research and findings,

original SME interviews, and specifications into a variety of procedural, instructional and

promotional tools. Senior level manager with experience supervising high profile, time-

sensitive projects and staff development with an emphasis on participatory management

techniques, quality team benchmarks and excellence.

Broad writing experience includes web content, scripts, proposals, slide kits, speeches,

storyboards, articles, white papers, technical and SOP manuals, user documentation,

business analysis, courseware development, flowcharts, testing, efficacy and scoring

templates, policies and procedures (including change management), functional & design

specifications, financial models, learning tools and promotional/publicity documents.

Deliverables: on-line products, CDs, print.

Tools

Management: MS Project 2000, Lotus Notes, Documentum, eDMS

Word Processing: Word, MS Office Suite, Lotus Notes

Desktop Publishing: PageMaker, PowerPoint, Publisher, Access, Excel

Help Authoring: PageMaker, SharePoint, TrackWise

Graphics: Visio, Nimbus, Fullshot, Snagit

Education

BA Albright College, Reading, PA

Professional

Certificates:

Instructor of Broadcast Television/ Television Production

NJ Teacher’s License

February 09

2

NJ Real Estate Agent’s License

Employment Experience

Consultant, ViewMedia Productions, Brielle, NJ 1985 - present

Domestic and international work as a consultant. Representative Titles include: Project

Manager, Senior Writer, Technical Writer, Producer, Director, Product Development

Manager, Courseware Developer, Curriculum Developer, Technical Supervisor, Trainer of

Trainers, Business Analyst, Reporter and Proposal Writer.

Representative Assignments

Sr. Technical Writer

ProTech Solutions Inc., Monmouth Junction, NJ (9/09-5/10)

Managed and edited enterprise-wide suite of documents in collaboration with Systems

Network Manager on transfer of custom application (NJKids) to NJ state ownership.

Authored series of 26 reports on system field tests for 18 county offices in working with

SNM and other SMEs, documenting results for corporate HQ and NJ State

overseers. Initiated, produced and edited all new (processes & procedures)

documentation, document fixes and training manual additions for client’s incoming

employees on new system.

Sr. Technical Writer/Business Analyst

Mellon Bank, Ridgefield Park, NJ (2/09-8/09)

Created new document suite of SOPs and Work Instructions for firm’s new customer

web application (MellonACT) dealing with Stock Options Grants and Participant (web)

interfaces. Worked with Project and Document Managers, UI group and SMEs in creating

32 documents detailing applications functionalities, maintenance and emergency

procedures. Assisted in the development, maintenance and updating of all policies and

procedures and relevant WI’s for MellonACT and peripherals.

Medical Writer

Red Nucleus, Hamilton, NJ (6/08-12/08)

Authored and contributed to an enterprise-wide suite of documents including disease

state backgrounders, job aids, executive summaries, workshops, mobile learning

units, audio CDs and assessment lessons for major pharmaceutical clients in tri-state

area. Typically multi-tasked several projects under stringent timelines with interactive client

input. Held to FDA, AMA, Chicago style and client standards, in drafting product

independently yet collaborating with PMs, other writers, editors, IDs, programmers, client

brand managers and trainers in bringing product to fruition. Content included DVT/PE,

COPD, OAB, PUD and chemotherapy.

Senior SOP Writer

Eisai Global Clinical Development, Ridgefield Park, NJ (12/07-5/08)

Created over 45 SOPs for IT, RA, Clin Ops, Corporate, Medical Writing, &

Biostatistics divisions as key member of Business Re-engineering Dept., a cross-

functional unit within Eisai. Collaborated with corporate SMEs in US, UK and Asian

groups in formulating on-going working practices (SWPs) and procedures (SOPs)

for multi-national corporation on important topics including process map drafts, clinical

trials, regulatory affairs submissions, information management protocols and

Kevin O’Keefe

Experience Highlights PAGE 3

disaster recovery plans. Sat on Business Re-engineering Committee, in enterprise-wide

effort to streamline and expedite all existing SOPs.

Business Analyst /Senior Tech Writer, QA

ProTech Solutions Inc., Monmouth Junction, NJ (3/07-11/07)

Supervised, wrote and validated content for a suite of 30 SDLC documents aimed at

client-facing applications on project (NJKids) overhauling NJ’s child welfare system.

Developed content for following plans: Configuration Management, Disaster Recovery,

System Capacity, System Application, Security, Software, System and Network

Architecture, Enterprise Architecture, Application Quality Assurance, Batch Process

Component Maps, Programmers’ Handbook and Statewide Network Survey Results.

Supervised all written elements on project interacting with client managers, internal

technical and content SMEs and peers.

Business Analyst /Sr. Technical Writer

Albridge Solutions, Lawrenceville, NJ (10/06-2/07)

Authored client-faced Security Assessment Response from a series of internal memos,

position papers, policy overviews, insurance data, HR policies & practices and Business

Continuity/Disaster Recovery Plans. Led conceptual and documentation team in

working closely with the CEO, CIO, Director of ISS and VP of HR in building successful

long-form document, enabling company to address immediate security gap and move

forward in negotiations with top tier clients.

Sr. Technical Writer/Business Analyst

Bristol-Myers Squibb, Princeton, NJ (2/06-9/06)

Co-authored series of Audit Reports in compliance with SEC mandated Sarbanes-

Oxley initiative for General Computer Controls division. Worked with Project Manager

and audit team in creating full documentation set including all COBIT Control Activities

with accompanying Test Plans, Test Scripts, Test Reports and cumulative Audit Reports

including Deficiencies, Management Attention (items) and general report description and

conclusion. Accounted for time-sensitive document set ( 200+ auditable documents)

maintained in Documentum. Contributed to CAPA TrackWise System rollout as Writer

and Tester and authored Design Spec for TrackWise EHS application aimed at

validated enterprise-wide utilization.

Business Analyst /Sr. Technical Writer

Pfizer Inc., Parsippany, NJ (6/05-12/05)

Authored a series of documents (22) aimed at streamlining CIT’s domain

documentation process. Worked with process owners and managers in targeting, refining

and documenting key areas impacted by Sarbanes-Oxley act . Provided consultancy,

advice, and support to members of CIT in order to ensure that accurate, timely and

consistent documentation reflected new domain structures and CIT’s divisional goals.

Provided evidence of compliance with legal, business and regulatory requirements

as per CIT Infrastructure Service SOPs. Administered the content, structure and

permissions for gCS Document Control repositories and team share areas.

February 09

4

Sr. Technical Writer

Bristol-Myers Squibb, Princeton, NJ (9/04-4/05)

Converted gap analysis assessment into project targets for enterprise-wide facilitation and roll-

out of automated eBatch and BRR (Batch Record Redesign) programs, applying SAP

to pharmaceutical (factory) processes, including international paper-based packaging and

labeling (manufacturing) operations. Key target issues included 21 CFR Part 11, GMPs

(SOPs), and strict Testing and Validation programs. Also played an integral part in Testing,

Validation and Documentation program facilitation aimed at incorporation into 30

facilities worldwide.

Project Manager/Writer

Astra Pharmaceuticals, Amsterdam, Holland (2/04-5/04)

Managed international medical symposium, hiring all vendors, supervising all content

and technical procedures, including camera, audio, record, talent, graphics, and editing

operations. Wrote overview, intros & outs for all program segments . Supervised

product edit for long form video, incorporating symposium with client presentations for

international audiences. Managed duplication effort in various formats & languages

for international distribution.

Kevin O’Keefe

Experience Highlights PAGE 4

Senior Technical Writer

Merck & Co., Inc., Rahway, NJ (4/03-12/03)

Wrote Application Support team’s (21 CFR Part 11) documentation for

major remediation effort in preparation for Requirements Traceability Matrix

input and FDA audit. Worked with development team in creating Functional

Requirements Specifications, Systems Design Specifications, Validation

Test Plan, User Guide and SOPs. Developed documents for Merck’s Clinical

Information System’s SMART application, a global software fix deployment

aimed at streamlining world-wide clinical data input and reducing IT man-

hours. Wrote majority of project documentation (1000 + pp), guiding

documentation to User Acceptance Testing and Requirements Traceability

Matrix stages.

Business Analyst /Sr. Technical Writer

Cardinal Pharmaceutical Health Development, Tampa, FLA (8/02-2/03)

Authored change management documentation and numerous original SOPs,

in prep of proposed Pilot Plant operational/validation as per 21 CFR Part 11

guidelines. Incorporated GMPs, GCPs, process details, facility parameters,

SME interviews and existing technical database into documents. Topical

areas covered included corporate change processes, operations, mixing,

cleaning and/or maintenance in key areas including: Zydis Freeze Tunnel,

Becomix, Hicks & Ystral Mixers, Powder Weigh-Off and Medicine Prep Extract

Booths, Vacuum Leak Tests (General and for Sachets), Markem Printers and

others.

Senior Writer

Visiting Nurse Services of New York, New York City, NY (12/01-6/02)

Wrote original functional specifications and SOPs aimed at integration of new

mainframe, tablet and browser system (Visits documentation) functionalities

into existing operation. Incorporated SME interviews, corporate culture and

user benefits into a series of documents, providing bridge between SAI

(clinical group) and IS (programming). Worked with programmers, clinicians,

and business analysts in fashioning series of over 40 functional specs,

detailing new system’s intent, purpose and functionality for programmers and end

users alike. Integral in implementing writing team’s cohesion, efficacy and project

staying power, bringing project in on time and on budget despite personnel and

system disruptions.

Project Manager/Business Analyst/Writer

JPMorgan Chase, Manhattan, NY (4/01-10/01)

Lead researcher, content developer and project manager for major portal

(eSource) reassessment in firm’s ongoing effort of eTransformation, a change

management process. Interfaced with Department Leads, Division Managers and

Lead Applications Developers in building documentation. Chaired Corporate

Kevin O’Keefe

Experience Highlights PAGE 4

Intranet Solutions group meetings. Interviewed end-users and SME’s across

the firm including those in application development, web design, finance and

eCommerce. Authored all documentation for final review by department heads

in preparation for (successful) Web Business 50 Awards presentation.

Reviewed/critiqued content presentation for establishment of focused online

project sites (QuickPlace).

Senior Producer/Writer

Amgen, Inc., Thousand Oaks, CA (8/00-2/01)

Co-writer/ Project Manager for “Hematopoiesis: Administrative Partnerships in

the New Age”. Directed and produced piece, supervised tape edit,

duplication and distribution. Deliverable showcased professional synergy in a

series of interviews with administrators and resident physicians at the

Health Sciences Centre, Winnipeg, CAN., Cedars-Sinai Hospital, Los Angeles,

CA, MD Anderson Cancer Center, Houston, TX, University Hospital, Cincinnati,

OH, Dartmouth-Hitchcock Medical Ctr., Hanover, NH and New England Medical

Center, Boston, MASS. Success of product served to underscore Amgen’s

position as leading supplier of Epogen and Neupogen.

Kevin O’Keefe

Experience Highlights PAGE 5

Representative Clients:

• •

Engineering Firms Bellcore

American Banknote

Holographics • Eastern Automated

• AT&T Systems

• •

Genlyte Levine Corp.

• •

Pharmaceutical/ Overlook Hospital

Amgen Inc.

Medical Clients • • Sloan-Kettering Med. Ctr.

AstraZeneca

• • Roche Labs

SmithKline Beecham

• • SMC MedComm

Hoffman LaRoche

• • Triclinica

Bayer

• •

Pfizer Novo Nordisk

• •

MD Anderson Cancer Ctr. Rhodia

• •

Merck & Co. Inc Bristol-Meyers Squibb

• •

Eisai Global Clinical Visiting Nurse Service of NY

• •

Businesses/ JPMorgan Chase Unisys

Corporations • •

National Telephone ProTech Solutions Inc.

•

Directory McBee Systems, Inc.

• Navesink Yacht Works • Prime Computer

• Mineral Water Co. • American Standard

Of Canada

• Mellon Bank

• Coopers & Lybrand

• United Chemical, Inc.

• Albridge Solutions

• Wolfe Computer

• •

Educational Neptune Township Board

Central Regional

Institutions School District Of Education

• •

Safe at Home, Inc. Drum Corp. International

• •

Communications National Geographic

Morrison Agency

Groups • • Paradigm Group

Sylvia Allen Agency

• • Coastline Group

Otterson TV

• • Lanmark Communication

The Lum Group

• • Video Arts

Tri-Ad Agency

• •

Real Estate Firms John Clapp Associates

For Rent Magazine

• • Avalon Bay Properties

Berkeley-Carteret Group

• •

Transportation Co.’s Walter Mihm Inc.

Coast Cities Corp.

• • 1 800 CAR LOAN

American Tours Ltd.

Kevin O’Keefe

Experience Highlights PAGE 5

• •

Political Groups NJ Republican Party

NJ Governor’s Office

• Nat’l. GOP Chairman

• •

Volunteer Work Oliver’s Twist

NJ Food Bank

• • NJ High Schools

Kids Count

• • March of Dimes

Pop Warner Football

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