Labeling Process Management

4 weeks ago

Albany, United States Donatech Full time
Position would require the candidate to be a W2 employee of Donatech
US Citizenship/Permanent Resident Required
FULLY REMOTE
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 client's 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.

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

Basic Qualifications:
Master's degree
OR Bachelor's degree and 2 years of related experience
OR Associate's 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)

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