Summary
Overview
Work History
Education
Skills
Websites
Professional Development
Timeline
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Stephanie Youker

Wilmington,MA

Summary

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

29
29
years of professional experience

Work History

Labeling Project (Kelly Services OCG) - Medical Device Labeling| Supply Chain| Regulatory

DEPUY SYNTHESIS, DIVISION OF JOHNSON & JOHNSON
11.2013 - Current
  • Executed label design and regulatory compliance of over 18,000 product codes and over 115,000 product labels for medical device finished goods within the Orthopedics market
  • Work within regulatory and packaging guidelines for project specific changes to medical device labels
  • Ensure labeling compliance of symbols, materials, legal manufacturer changes, product logos, translations, barcode verification and other labeling requirement for MDR, MDD, and UDI regulations for US, EU, China and other markets
  • Collaborate with cross functional teams to determine label specifications and regulatory guidelines
  • Create, maintain, and proof label records and templates utilizing barcode and PLM software programs
  • Helped implement tracking system for reporting performance metrics, this system was instrumental in changing corporate procedure for proofing labels, as it showed metrics justify and verifying more streamlined approach based on data captured
  • Created and managed system to accurately track and execute thousands of label records which enabled hundreds of label templates to be combined into more streamlined process to ensure on-time execution delivered ahead of schedule
  • Coordinate cross functional requirements for labels between regulatory, packaging, IFU's, legal and marketing ensuring that all materials match necessary requirements for compliance and regulatory submissions
  • Collaborate on writing procedure updates for label request changes as outlined by FDA guidelines and other contributing factors that would affect change to label, IFU and marketing content
  • Extensive work with data driven content software program and systems such as, Loftware, Prysm, Bartender, Windchill and Agile
  • Maintained consistent work environment, overseeing intricate daily tasks with minimal supervision
  • Used critical thinking to break down problems, evaluate solutions and make decisions
  • Worked well in team setting, providing support and guidance
  • Skilled at working independently and collaboratively in team environment
  • Provided professional services and support in dynamic work environment
  • Applied effective time management techniques to meet tight deadlines
  • Paid attention to detail while completing assignments

Software Integrator Advisor for Manufacturing Companies. Compliance Labeling, Supply Chain Management, Barcode Design

PRAGMATYX
11.2013 - 02.2018
  • Project Management of labeling initiatives: define scope, build onsite team for contract clients, execute timelines, report to onsite management, and execute milestones
  • Project execution for medical device company, which included design and deployment of world-wide product labeling (document control) system that meets compliance requirements instituted by various franchises. Included PLR conversion, PLR compliance, new and revisionary safety labeling changes and database management
  • Created new brand identity and new company positioning, including new website, introduction of social media, trained and wrote scripts for inside sales and created outbound marketing materials
  • Improved processes by recommending operational changes
  • Built and maintained relationships with clients to provide ongoing support

Director of Marketing

HONEYWELL BATTERIES
05.2010 - 05.2011
  • Worked with engineering on execution of new products and define customer beta sites to validate need within market
  • Conduct market research and outline new product opportunities within existing target vertical markets
  • Led team of marketing professionals, offering mentoring and coaching to build knowledge and skills.
  • Coordinated with creative team to generate dynamic marketing content and communication tools for promotional campaigns.
  • Organized and executed robust, creative experiential marketing events.
  • Boosted brand awareness and generated leads while managing internal and external marketing campaigns and programs.

Director of Marketing/Brand Ambassador

DRIFIRE, INC.
12.2006 - 04.2010
  • Charged with creating brand, defining product positioning, conducting market research and expanding new market and sales opportunities
  • Managed three agencies with teams of 5-25 personnel
  • Marketing programming helped to drive company growth from $100K in 2007 to $18MM in 2009
  • Uncovered consumer insights and competitive advantages via quantitative and qualitative research to define advertising campaign, sales tools and tradeshow presence as well as develop new products
  • Implemented new website with state-of-the-art e-commerce system from scratch, including all writing and design direction based on corporate goals and objectives
  • Created highest search rankings for keyword category within very short time frame
  • Introduced and developed new product categories that expanded product line and helped sell into all new markets, increase brand visibility, and open new sales channels and categories
  • First six months' sales $100K, first year $1M and end of 2009 was $18M
  • Created new sales distribution strategy that realigned top tier distributors in personal protection category to forecast and take stocking inventory of new introductory product line
  • Established grassroots social media channels into integrated communications program, including SEO, blogs and pay-per-click programs that helped create and define e-commerce sales strategy and Internet marketing campaign

Marketing and Corporate Communications Executive

LOFTWARE, INC.
04.2002 - 12.2006
  • Responsible for creating marketing strategy and overseeing tactical execution of marketing initiatives, including alignment of strategic marketing objectives with corporate sales and growth objectives
  • Led execution of fully integrated, multichannel marketing communications which included new website launch from scratch, all writing, positioning and creative direction
  • Managed development, implementation and measurement of Web-based and traditional marketing campaigns, including search engine optimization, pay per click advertising and print advertising
  • Led event marketing initiatives including key messaging and booth design
  • Drove all public relations activities and served as corporate spokesperson
  • Managed partner relations and oversaw alliance management
  • Spearheaded product innovation and re-launch which led to 40% increase in new business within 14 months

Director of Marketing

PHONETIC SYSTEMS
12.2000 - 01.2002
  • Defined new market strategies and developed business plans and marketing budgets to position company for future growth
  • Boosted brand awareness and generated leads while managing internal and external marketing campaigns and programs
  • Developed and implemented successful marketing strategies to increase brand visibility and sales performance
  • Organized and executed robust, creative experiential marketing events

Director, Marketing Communications - Worldwide

LERNOUT & HAUSPIE
02.1996 - 12.2000
  • Developed and managed worldwide budget of approximately $25M
  • Responsible for all worldwide marketing including creating and executing country-specific marketing programs to drive sales and corporate objective
  • Recruited, managed, and mentored more than 20 associates including marketing managers, Web team and event marketing personnel
  • Directed global brand identity initiative related to integration of 49 corporate acquisitions into L&H's brand family.
  • Managed daily operations while overseeing multiple locations to foster increased productivity.
  • Worked closely with organizational leadership and board of directors to guide operational strategy.
  • Managed outside design, advertising and public relations agencies.
  • Developed market research programs and executed marketing programs and content to increase sales and brand positioning based on research findings.
  • Established promotional “partner program" with customers, VARs and resellers to help drive additional customer support, resulting in earlier adoption of speech technology.

Marketing Communications Manager

T CELL DIAGNOSTICS, INC.
06.1995 - 02.1996
  • Managed design and production of all aspects of marketing communication for the Trax brand including brochures, direct marketing, event materials and promotions
  • Initially hired as Marketing Specialist in September 1994; promoted to Marketing Communications Manager in June 1995
  • Managed sales lead database and measured potential ROI based on marketing programs and events
  • Coordinated analyst and press interviews with scientists

Education

Associates in Business Marketing -

Lasell College
Newton, MA

Skills

  • Time Management
  • Relationship Building
  • Attention to Detail
  • Self Motivation
  • Multitasking
  • Teamwork and Collaboration
  • Excellent Communication
  • Task Prioritization
  • Organizational Skills
  • Decision-Making

Professional Development

  • Strategic Marketing of High Technology Products, CALTECH University, Pasadena, Calif.
  • Marketing of High Technology Products, AEA/Ivey Executive Conference
  • Utilizing the Internet for Today's Environment
  • Branding High-Tech Applications over the Internet, Jupiter's Internet Marketing Conference

Timeline

Labeling Project (Kelly Services OCG) - Medical Device Labeling| Supply Chain| Regulatory

DEPUY SYNTHESIS, DIVISION OF JOHNSON & JOHNSON
11.2013 - Current

Software Integrator Advisor for Manufacturing Companies. Compliance Labeling, Supply Chain Management, Barcode Design

PRAGMATYX
11.2013 - 02.2018

Director of Marketing

HONEYWELL BATTERIES
05.2010 - 05.2011

Director of Marketing/Brand Ambassador

DRIFIRE, INC.
12.2006 - 04.2010

Marketing and Corporate Communications Executive

LOFTWARE, INC.
04.2002 - 12.2006

Director of Marketing

PHONETIC SYSTEMS
12.2000 - 01.2002

Director, Marketing Communications - Worldwide

LERNOUT & HAUSPIE
02.1996 - 12.2000

Marketing Communications Manager

T CELL DIAGNOSTICS, INC.
06.1995 - 02.1996

Associates in Business Marketing -

Lasell College
Stephanie Youker