Label Development Specialist
Astrix Technology
Label Development Specialist
Manufacturing
Ridgefield, CT, US
Pay Rate Low: 41.00 | Pay Rate High: 44.00
+ Added - 31/10/2024
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_Our client is a global leader in clinical research, dedicated to developing innovative treatment options for various medical conditions. The company is seeking a Label Development Specialist to join their team!_
**Location:** Ridgefield, CT
**Shift:** Hybrid
**Key Responsibilities:**
+ Review Master Label Text drafts for compliance with regulatory requirements and trial specifics.
+ Prepare country-specific label texts for translation and review translated texts for accuracy.
+ Review and check generated print proofs, distributing them for approval to relevant countries.
+ Collaborate with global Trial Teams, Regulatory Affairs, Medicine, and label vendors to optimize labeling tasks.
+ Ensure all teams and vendors adhere to timelines and provide updates on IMP labeling milestones.
+ Compile and provide completed label documentation for final release to the Release and Process Management Team.
+ Act as the main contact for vendors and countries regarding the labeling process, addressing all inquiries.
**Qualifications:**
+ Master’s Degree in a related field or equivalent professional training with extensive experience.
+ Background in Clinical Trials, specifically in Supply Chain, Clinical Trial Regulations, and Packaging and Labeling.
+ Demonstrated knowledge of clinical supply chain activities and applicable regulations (e.g., CTR 536/2014).
+ Ability to work independently and collaboratively in a global team environment.
+ Proficient in Microsoft Office and fluent in English.
INDBH
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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