Project Manager Quality Assurance

SUMMARY

A self-motivated accomplished professional graphics specialist II, medical

editor, proofreader, designer, fine artist and farmer and that managed

projects from start to finish. Thrive in chaotic environments where there

is a combination of smart talented people that have a human touch to

succeed. Extremely passionate about helping businesses grow while reaching

out and helping my colleagues succeed in the office environment. Have an

entrepreneur spirit that enjoys change, learning, growing and being

creative. My strength is effective interpersonal and communication skills

with the ability to listen.

PROFESSIONAL EXPERIENCE

Special Projects

Doylestown, PA 18901

11/2012 - present

Mentoring and offering support to former colleagues and friends who are

seeking employment. Volunteering my expertise while providing Technical.

Writing with New Resumes, Cover Letters and Thank You Letters. In addition,

helping people connect with various recruiters.

McNeil Consumer Healthcare

GLOBAL Regulatory Operations

LABELING (Division of Johnson & Johnson Consumer Companies, Inc)

Fort Washington, PA 19034

Graphic Specialist II/Copy Development Project Manager (long-term Contract)

11/2010-11/2012 (2 years)

. Provides support to the Copy Development Project Manager related to the

development, approval, and release of packaging and labeling graphics for

McNeil Consumer Healthcare

. Provides graphics input into labeling and packaging documentation,

including scope control documents, BOM set up forms, and material

specifications

. Reviews and analyzes change controlled documents

. Trafficking artwork creation and corrections thru graphics vendors

. Assigned component part numbers to labeling components

. Routes all labeling artwork for proofreading

. Communicates project timelines and status for assigned projects

. Tracks color standard development, approval, and distribution to incoming

QA inspection

. Collaborating with cross-functional teams, Packaging Engineering,

Regulatory Affairs Franchise, Regulatory Labeling, Quality Assurance, Legal

(Patent and Trademark), Technical Operations, Quality Assurance, Planning,

Copy Development Project Managers and Proofreaders

. Worked on specific brands, Motrin IB Caplet, Motrin PM, Benadryl Ultra

Tabs, Children Benadryl Liquids, Imodium, and Tylenol

. Maintain a daily label log and related metrics in Word Access, Excel,

SharePoint and EDM

. Updating all graphic information in the EDM and database applications

. Creation of checklists for all labeling artwork for efficiency and good

medical practices.

. QN writing experience

. Adhering to strict compliance with Good Medical Practices

ADDITIONAL INFORMATION

. Knowledge of labeling artwork development and approval processes

. Good communication & organizational skills

. Experience working with cross-functional teams

. Working knowledge of all Microsoft Office applications

. EDM knowledge

. Strong Problem-solving skills

. Ability to work independently and demonstrated ability to perform as a

team player

. Willingness to provide support where & when needed

. Enjoys working in a fast paced environment

. Strategic Thinker

. Detailed oriented

. Current with SOPs training related to the job function

Euro RSCG Life Catapult, Princeton, NJ

AMA Medical Editor, Freelance (12/2009 - 03/2010)

Promotional Advertisement

. Initial edits

. Cold reads

. Check changes including all graphics, multimedia, websites and charts

. Editing and proofreading

. Fact checking marketing materials for pharmaceutical clients (Sanofi

Aventis, Novartis)

. Review Safety Information and Black Box Warnings

. Worked in a team environment

. Collaborating directly with internal and external customer base

. Selected to participate in pre-launch of new marketing materials and

upcoming sale pitches

. Managed key assignments when asked

. Strong knowledge of AMA Style of Writing

. Worked in PowerPoint when necessary

United Healthcare Insurance Company, Ovations Insurance Solutions Horsham,

PA

Proofreader/Editor - Contractor (03/2008 - 6/2009)

. Responsible for proofreading and editing

. Trafficking campaigns- adhering to tight deadlines

. Shared ownership for two DM (Direct Mail) Campaigns and special projects

. Conducted quality assurance-reviewing and recording in excel spread sheet

DM sample materials (seeds)

. Provided feedback to managers/vendors on approved sheets

. Coordinated/maintained a document filing system for team with easy

friendly user access resulting in improved organization

. Volunteered to review and edit website campaigns

Wyeth, Collegeville, PA

GLOBAL LABELING

Medical Technical Proofreader - Contract (1/2007 - 10/2007)

. Experience with the technical editing process for US Submissions in

SPL/XML, Word and PDF Formats

. Experience with SPL IN THE US and PIM and in the EU across the

organization following strict FDA Regulations

. Reviewed Labeling SPL/XML files prepared for submission to FDA or as the

source for numerous rendition output via style sheets. Core Data Sheet

(CDS)

. Working closely on projects with document manager with therapeutic area

leaders, label managers, document specialist, proofreaders and management

. Performed document comparisons and preparation in various applications,

adhering to the processes outlined in the SOP and checklist

. Given ownership of special project, worked with programmers and

validation team players Validating Physicians Labeling Rule (PLR) style

sheet and epic editing tool in a controlled strict testing environment

Bristol-Myers Squibb, Plainsboro, NJ

AMA Medical Proofreader/Editor - Contract (2/2006 - 1/2007)

Promotional Advertisement

Proofread all designs and copywriting projects

including all PDF:

. Slide decks

. CDROMs

. Web pages

. Sale carriers, slim Jims, visual aids

. PIs, ISIs, and Brief Summaries

. Clinical trials posters and advertisements for magazines, press releases,

autobiographies, all marketing and commercial scripts

. Adhering to AMA style and consistency

. Worked with DDMAC Form FDA 2253 submissions

. Annotated documents in CRISP- correction and line checks, full reads,

stamping approved hardcopy

. Electronically proofread documents in Mercury and Crisp

. Chosen to participate on quality control project with Mead Johnson Audit

for each promotion in the bi-weekly Direct Mail Campaign verifying files

and validating records

. Worked overtime to meet deadlines

Bristol-Myers Squibb, Hopewell, NJ

Senior Administrative Associate - Contract (9/2005 - 2/2006)

. Provided administrative support services

. Tracking all project hours

. Scheduling onsite meetings and teleconferences

. Arranged travel and expense reporting

. Maintained ongoing tracking spreadsheet

. Creation of PowerPoint slides

. Assisted with special projects

Borgata, Casino, Spa, Atlantic City, NJ

Customer Care Representative/Special Projects (4/2004 - 9/2005)

. Responsible for answering inbound telephone calls in a customer service

Skill-based call center. Transactions ranged from the call transfers to in-

room work order requests (order entry), to complex hotel, dining, and event

and entertainment reservations for VIP customers. Catered to customer needs

using tact and diplomacy

. Participated on Special Project Events and promotions working closely

with clients and management, dealt with highly confidential information on

a daily basis

ConvaTec (former division of Bristol-Myers Squibb), Skillman, NJ

AMA Proofreader/Traffic Coordinator

LABELING AND PACKAGING

Proofreader / Project Associate - Contract (2/2003 - 10/2003)

. Managed key assignments for a medical supply company that specializes in

ostomy, wound care and skin care products

. Proofread 15+ Languages on the Global Visioning System

. Directly communicated with third party vendors

. Coordinated special projects, such as researching database and compiling

background history in collaboration with vendors who performed graphic

production for ConvaTec

EDUCATION

. Moore College of Art and Design, Philadelphia, PA - Certification in

Desktop Publishing and Computer Graphics (completed Certification

Program)

. Beaver College, Glenside, PA - Graduate studies in Special Education

(completed studies)

. Temple University, Philadelphia, PA - Bachelor of Science in Education

(completed)

. Bucks County Community College, Newtown, PA - Fine Art, Computer Graphics

Design, Metal smith coursework (ongoing)

. Montgomery County Community College, PA Associate Degree in Education

(completed)

TECHNICAL SKILLS

Mac/PC platforms Adobe Illustrator Global Vision Proof

Reading System

Microsoft Office (Word, Access Quark

Excel, PowerPoint

Visio Adobe Acrobat SAP

CRISP Epic Editor Diffdog

Mercury Arbortext (XML

comparison tool EDMS data management

Cmat SharePoint OUTLOOK

Altova Authentic WIZARD Training database Photoshop

May 2014

Dear Project Manager:

Experience stems from 15 years in the pharmaceutical industry. I've worked

in Marketing and Advertisement, Clinical Research, Clinical Studies,

Oncology, Global Regulatory Affairs, Global Labeling and Customer Service.

I believe in strong communication skills that make a difference that

continue to grow in an upward spiral to success. Primary duties were but

not limited to managing brand assignments, joggling projects from start to

completion, managing mail order campaigns, developing controlled documents,

trafficking, fact-checking, editing, proofreading and writing.

Have collaborated with Art Directors, Medical Editors, Graphic Designers,

Print Buyers, PowerPoint Specialists, Prepress Specialists, Document

Specialists, Graphics Specialists, Account Executives, Traffic

Coordinators, Copywriters, Programmers, Regulatory Affairs Associates,

Therapeutic Area Leaders, Medical Affairs, Packaging and Labeling

Engineers, Marketing, Legal (Patent and Trademark), Quality Assurance,

Vendors and Project Managers.

Have the innate ability and talent to work in a fast-paced environment that

successfully juggles multiple priorities. Creative, adaptable, flexible and

organized that enjoys helping my colleagues succeed in the office

environment that steadily increases company's profits and productivity.

Have an entrepreneur spirit that enjoys change, learning and growing.

Thank you for this opportunity.

Regards,

Janice Eiseman

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