Marketing & Sales Associate
April 2005 to January 2010
Graphic Design Intern
November 2008 to February 2009
Medical Supplies Graphic Designer
April 2013 to January 2014
Greater Boston Area
Manager, Artwork and Labeling
May 2018 to November 2019
Greater Boston Area
Senior Labeling Specialist
July 2016 to May 2018
Mitek Sports Medicine
Label Designer, Mitek Sports Medicine
August 2014 to July 2016
Greater Boston Area
Corporate Marketing Graphic Designer & Project Manager
January 2010 to April 2013
Greater Boston Area
Respiratory & Monitoring Solutions Lead Graphic Designer
January 2014 to August 2014
Created retail advertising signage, seasonal brochures and newsletters. Developed a social media presence to draw in new customers and spread wine knowledge. Created retail advertising signage, seasonal brochures and newsletters. Developed a social media presence to draw in new customers and spread wine knowledge.
What company does Lindsey Goller work for?
Lindsey Goller works for Walpole Wine
What is Lindsey Goller's role at Walpole Wine?
Lindsey Goller is Marketing & Sales Associate
What industry does Lindsey Goller work in?
Lindsey Goller works in the Biotechnology industry.
Marketing & Sales Associate @ Walpole Wine Created retail advertising signage, seasonal brochures and newsletters. Developed a social media presence to draw in new customers and spread wine knowledge. From April 2005 to January 2010 (4 years 10 months) Walpole, MAGraphic Design Intern @ Island Oasis Designed marketing signage and promotional items for multiple clients. Worked with photographers and the marketing team to develop artwork for company catalogs, posters and ads. Worked closely with the in-house print shop to ensure the quality of press samples. From November 2008 to February 2009 (4 months) Walpole, MAMedical Supplies Graphic Designer @ Covidien Designed product artwork based on new FDA regulations, which called for a unique device identifier (UDI) to be placed on all existing products and new acquisitions. Ensured that all packaging templates and executions adhere to Covidien design guidelines and global regulations. Collaborated with global manufacturing plants, in-house engineers, regulatory personnel and data management teams. From April 2013 to January 2014 (10 months) Greater Boston AreaManager, Artwork and Labeling @ bluebird bio An entrepreneurial and highly motivated labeling manager with broad experience and expertise developing, implementing, and overseeing artwork and labeling solutions for our clinical and commercial products. Working closely with our internal Regulatory, Manufacturing, Clinical and Commercial teams as well as our network of external manufacturers and suppliers to define and implement artwork and labeling strategies for our various clinical and commercial products. Additionally, defining and implementing robust processes and procedures for managing artwork and labeling solutions and strategies. From May 2018 to November 2019 (1 year 7 months) Cambridge, MassachusettsSenior Manager @ bluebird bio Senior Manager, Artwork and Labeling - Global Supply ChainBroad experience and expertise strategizing, developing and implementing artwork and labeling solutions for bluebird's clinical and commercial pipeline. Working closely with our internal Regulatory Strategy & CMC, Manufacturing, Quality, Apheresis Operations, Patient Operations, Software Development, System Integration, Clinical Development and Commercial teams as well as our network of external manufacturers and suppliers to define and implement artwork and labeling strategies to assist in meeting patient needs, on a global scale. Additionally, defining and implementing robust processes and procedures for label control, design standards, while aligning to regulatory authority expectations. Greater Boston AreaSenior Labeling Specialist @ Teleflex Incorporated Regulatory Affairs/ Quality Assurance - Cardiac Care• Coordinate and complete label creation and updates for the 2016 GS1 UDI deadline. • Rework and establish design guidelines and work instructions to implement new labeling strategy.• Coordinate process qualification validations with manufacturing and quality engineers. • Manage In-Country Reviewer correspondence, proposals and approvals, in harmonization with translation house recommendations and feedback. • Design Instruction for use layouts and content.• Partner with local Manufacturing, R&D and Quality teams for project planning and execution.• Prepares printed components and support documentation for regulatory 510k submissions• Ensures labeling reflects high quality barcodes that comply with GS1 guidelines and FDA UDI regulations.• Coordinates labeling equipment and software set up and maintenance and assists with process qualifications.• Supports external and internal regulatory audits to provide timely access to documentation related records.• Sustains relationships with external vendors, GS1 UDI core team as well as external customers.• Supports CAPAs and NC’s as required. From July 2016 to May 2018 (1 year 11 months) Chelmsford, MassachusettsLabel Designer, Mitek Sports Medicine @ Mitek Sports Medicine Responsible for managing and designing labeling content and development, including revision and review for developmental and marketed products. An emphasis is placed on compliance, innovation, document management and version control. I interact with technical experts, product managers, international manufacturing sites and regulatory management to assure that all Mitek labeling is maintained and accessible, and submission needs are met in a timely and efficient manner. Cross-functionally, I work with members of regulatory, legal, quality, manufacturing, and R&D globally.• Design labels used on finished good product that meets business and industry regulations, including 21 CFR 801 (US) Medical Device Labeling, EN 980 and ISO 15223 Medical Device symbols. Determine symbology requirements to meet FDA and BSI regulations; responsible for ensuring label design meets packaging requirements, and direct label stock vendors to create new label stock to meet business needs.Project Management:• Engage with business stakeholders to create and execute project timelines. Manage the work of external suppliers and facilitate release through two independent quality systems both internal and external to the organization. Update Device Master Records (DMRs) as required.• Manage internal documentation requirements including change controls, specifications, item code creations and artwork libraries. Maintain management of color and font standards.• Support external and internal regulatory audits to provide timely access to documentation related records.• Guide process & procedural improvement by supporting the use of current tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.• Serve as the primary information base for all issues related to product labeling/printed components. Monitor overall artwork management process and implement continuous improvement approach. From August 2014 to July 2016 (2 years) Greater Boston AreaCorporate Marketing Graphic Designer & Project Manager @ Covidien Covidien, Corporate Marketing Rebranding ProjectGraphic Designer and Project ManagerDesigned product artwork, corporate collateral and global marketing material such as PowerPoint presentations, brochures, diagrams, e-blasts, templates, posters, retouched, organized and documented product and corporate photography and also collaborated as a team to create a new brand strategy and corporate design guidelines. Also, as a project consultant to the Medical Supplies business unit, I was the liaison and problem solver from a global branding and management perspective. I was in constant contact with manufacturing plants, regulatory personnel, product marketing managers, engineers and outside vendors to ensure corporate guidelines and production qualifications were met. From January 2010 to April 2013 (3 years 4 months) Greater Boston AreaRespiratory & Monitoring Solutions Lead Graphic Designer @ Covidien Lead the Artwork design team for the Respiratory & Monitoring Solutions business unit. Created Unique Device Identification (UDI) specific design guidelines as well as product artwork, which adhered to Covidien design guidelines and Agile CDP regulations.Collaborated with global manufacturing plants, engineers and data management teams, I was able to provide and ensure accuracy and proficiency throughout the course of a multi-year project. From January 2014 to August 2014 (8 months) Boulder, Colorado
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
1 year(s), 11 month(s)
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