-- Labeling Process Management
Posted on :
08-03-2024
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Job Description
Req ID : 2605758
Job Title: Labeling Process Management
Job Duration: 12 months Contract on W2
Job Location: REMOTE
Job Duration: 12 months Contract on W2
Job Location: REMOTE
Note: US Citizen or Perm Residents/GC required for this position
Job description:
The purpose of the Global Labeling Strategy and Compliance (LSC) group is to develop and maintain core labeling documents to provide quality product labels and drive global labeling strategy to ensure safe and effective use of *** products for patients and healthcare providers around the world.
As part of Global Labeling Strategy and Compliance and under the supervision of the LPM management the Labeling Process Management Senior Associate supports the Labeling Process Management team to manage Labeling Process
Management activities.
Principal responsibilities include but are not restricted to:
Support labeling activities associated with legal entity manufacturing change.
Collaborate with Local *** Affiliates along with Regional Regulatory Affairs and Operations colleagues to plan and implement label changes ensuring compliance with labeling processes.
Process and system support.
Provide artwork source text and process support as necessary.
Participate in Labeling Submissions meetings to provide input on labeling processes.
Provide regional operational support for labeling.
Support labeling activities associated with legal entity manufacturing change.
Collaborate with Local *** Affiliates along with Regional Regulatory Affairs and Operations colleagues to plan and implement label changes ensuring compliance with labeling processes.
Process and system support.
Provide artwork source text and process support as necessary.
Participate in Labeling Submissions meetings to provide input on labeling processes.
Provide regional operational support for labeling.
Knowledge and Skills
Previous experience working in industry in support of Global Labeling Regulatory.
Works well independently and within teams
Use of document management tools
Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact diplomacy and respect
Time and project management skills
Ability to take initiative and drive results
Tolerance for ambiguity
Proficiency in anticipating and resolving problems
Oral and written communication and presentation skills
Relationship management
Previous experience working in industry in support of Global Labeling Regulatory.
Works well independently and within teams
Use of document management tools
Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact diplomacy and respect
Time and project management skills
Ability to take initiative and drive results
Tolerance for ambiguity
Proficiency in anticipating and resolving problems
Oral and written communication and presentation skills
Relationship management
Must Have Skill Sets:
Must have experience regional labeling/ artwork
Familiar with document management systems
Must have experience regional labeling/ artwork
Familiar with document management systems
Basic Qualifications:
Masters degree
OR Bachelors degree and 2 years of related experience
OR Associates degree and 6 years of related experience
OR High school diploma/GED and 8 years of related experience
Masters degree
OR Bachelors degree and 2 years of related experience
OR Associates degree and 6 years of related experience
OR High school diploma/GED and 8 years of related experience
Preferred Qualifications:
Degree in pharmaceuticals natural science or medicine
Previous experience working in industry in support of global labeling
Project Management
Fluent in English (oral and written)
Degree in pharmaceuticals natural science or medicine
Previous experience working in industry in support of global labeling
Project Management
Fluent in English (oral and written)
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Employment Type
Full Time
Key Skills
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