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Labeling Specialist - Business Unit Labeling Specialist, Global
IRVINE CA 92604
Category: Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-85068089

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Edwards Lifesciences

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  Job posted:   Sun Feb 25, 2018
  Distance to work:   ? miles
       
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Labeling Specialist - Business Unit Labeling Specialist, Global
Job description:





A Business Unit Labeling Specialist is a labeling representative and subject matter expert (SME) that collaborates with Business Unit customers and cross-functional stakeholders (Regulatory, Packaging, Quality, Marketing, NPD etc.) to deliver successful labeling changes and requested new labeling. This Labeling Specialist consolidates labeling requirements and scope, and timelines for labeling changes required for new product project teams and for other sustaining business needs.





A Business Unit Labeling Specialist drives labeling activities to initiate and to deliver to Operations labeling content changes through updates to product labels, instructions for use (IFU) and other forms of regulated labeling materials, in compliance with global and regional standards and regulations. This role is responsible for engaging cross-functional teams to resolve obstacles, meet key labeling objectives, and collaborate on continuous improvement initiatives.





A Business Unit Labeling Specialist support development of solutions for labeling initiatives, including recommending activities involving:




+ Legacy and new documentation and change management systems and processes

+ Country-specific requirements, including relevant standards and regulations

+ Root cause analysis and other process improvement techniques

+ Internal and external global stakeholders.







Responsibilities:




+ Confer with label package change initiators to assess business needs and to determine their requirements in order to help solve problems in an innovative, cost effective and timely manner

+ Establish personal rapport and achieve acceptance with cross functional team members by explaining labeling processes and developing compliant cost effective, fast-to-market solutions.

+ Build sustainable relationships of trust through open and collaborative communications

+ Collaborate with label change request initiators to plan, prepare and submit complete and accurate change requests.

+ Drives labeling activities to initiate and deliver to Operations labeling content changes through updates to product labels, instructions for use (IFU) and other forms of regulated labeling materials in compliance with global and regional standards and regulations.

+ Interpret, analyze, compare and make decisions regarding existing content in a labeling content system, in collaboration with labeling stakeholders, to support the design of labels and IFUs

+ Contributes to the development of solutions and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations, and labeling stakeholders

+ Evaluates risks, identifies alternatives, and proposes labeling approaches to resolve critical issues

+ Provides guidance to management in identifying/executing alternate strategies to facilitate or accelerate delivery

+ Prepare and deliver training presentations explaining services and processes of Global Labeling to different Business Units.

+ Attends project meetings including Project initiation meetings, Operational meetings, etc.


Qualifications:


Required Education/Skills/Experience:




+ Four-year college science-related Degree (Bachelors)

+ Minimum of 3 years labeling experience, preferably in the following areas:

+ Developing labeling for medical devices for FDA and global markets.

+ Developing or improving documentation (e.g. SOPs) in an FDA regulated industry.

+ Strong interpersonal skills are a valuable characteristic for business unit labeling specialists, both for building relationships with cross functional teams quickly, as well as effectively communicating with other members of the business unit.

+ Project Management Professional desired

+ Strong relationship management and communication skills, both oral and written (minimum English), in order to influence others and operate effectively with ambiguous situations.

+ Customer orientation and ability to adapt/respond to different types of characters

+ Must be able to listen to the customer's requirements, desires and concerns, and then recommend solutions, possibly including customizing a path forward to a variety of problems of moderate scope and complexity.

+ Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis

+ Moderate Knowledge of medical or pharmaceutical regulations and standards relating to labeling and regulated documentation

+ Action-oriented and customer-focused to deliver consistent, quality results

+ Ability to function well under pressure

+ Flexible to balance day-to-day delivery at the same time as unanticipated activities

+ High level of detailed accuracy

+ Experience with content management, translation, labeling graphics design and proofreading systems desirable

+ Skills in Microsoft Word, Excel, PowerPoint, and Outlook required

+ Good knowledge of project management software tools such as Microsoft Project #LI-MA1


About Edwards

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.





For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.


Title: Labeling Specialist - Business Unit Labeling Specialist, Global Labeling
Location: USA-USA-California - Irvine
Job Number: 013178

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