Cheryl Whalen
Labeling Project Coordinator
Depuy Labeling Project Coordinator at USDM Life Sciences
Greater Boston Area
Section title
Cheryl Whalen's Email Addresses & Phone Numbers
Cheryl Whalen's Work Experience
USDM Life Sciences
Labeling Project Coordinator
Cardinal Health
Regulatory Rebranding Specialist
May 2020 to July 2020
Mansfield, Massachusetts, United States
Medtronic
Contract Manufacturing Sr. Project Coordinator
May 2018 to May 2020
Boston Scientific
Technical Writer
August 2017 to May 2018
Marlboro, MA
Covidien (Medtronic Minimally Invasive Therapies Group)
Labeling Project Coordinator, UDI OEM Customers
September 2014 to May 2017
Mansfield, MA
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Frequently Asked Questions about Cheryl Whalen
What company does Cheryl Whalen work for?
Cheryl Whalen works for USDM Life Sciences
What is Cheryl Whalen's role at USDM Life Sciences?
Cheryl Whalen is Labeling Project Coordinator
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What is Cheryl Whalen's business email address?
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What industry does Cheryl Whalen work in?
Cheryl Whalen works in the Medical Devices industry.
Who are Cheryl Whalen's colleagues?
Cheryl Whalen's colleagues are Shani Frenkel, Andy Cohen, Gary Suszynski, Caitlyn Rosendahl, Lisa Maturo, Gilberto Martinez, Steve Deyoe, Ravinder Grewal, Kevin Fowler, and Dan Sorensen
About Cheryl Whalen
📖 Summary
Labeling Project Coordinator @ USDM Life Sciences Regulatory Rebranding Specialist @ Cardinal Health Participate in cross-functional teams supporting label rebrandingPartnering with Regulatory Product Specialists, provide regulatory assessment of change on label changesSupport the Change Development Process through planning, review, execution, and approval of label changesReview and approve label artwork changes for compliance with global labeling regulations and product filingsIn collaboration with International Regulatory Affairs, determine applicable registration requirements and assist in preparation of documentation to support re-registration of label changesMaintain regulatory systems and produce various reports as needed From May 2020 to July 2020 (3 months) Mansfield, Massachusetts, United StatesContract Manufacturing Sr. Project Coordinator @ Medtronic Resources Global Professionals at CovidienProject Coordinator UDI/SAP ProjectCommunicate with Contract Manufacturer, Global Business Unit, Marketing, Regulatory and Engineering to bring products sourced from them into current UDI/SAP standardsEducate Contract Manufacturer on UDI and SAP if necessaryTrack project status in Microsoft ProjectDevelop and manage Engineering CDPs until closed for CM customers From May 2018 to May 2020 (2 years 1 month) Technical Writer @ Boston Scientific Enhanced Compliance Inc at Boston ScientificTechnical Writer of IFU's based on the acquisition of American Medical SystemsWork closely with Marketing, Regulatory, Clinical, Artwork Designers and Engineering to develop bring current AMS IFU's to Boston Scientific StandardsMake changes to IFU's based on outcome of meetingsProvide team with most comprehensive IFU to review before routing in Boston Scientific From August 2017 to May 2018 (10 months) Marlboro, MALabeling Project Coordinator, UDI OEM Customers @ Covidien (Medtronic Minimally Invasive Therapies Group) Manage projects with OEM Customers to ensure compliance with FDA UDI rulingEducate OEM Customers and present material related to the FDA's regulation, conduct label artwork reviews, assist in barcode verification implementationAlign with cross functional groups (Graphics, Quality, Logistics, Regulatory, Engineering and Marketing) to ensure timely completion of projectsCreate and manage CDPs for OEM Customers From September 2014 to May 2017 (2 years 9 months) Mansfield, MA
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In a nutshell
Cheryl Whalen's Personality Type
Extraversion (E), Sensing (S), Thinking (T), Perceiving (P)
Average Tenure
1 year(s), 5 month(s)
Cheryl Whalen's Willingness to Change Jobs
Unlikely
Likely
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