We are currently searching for a skilled professional to join a well-known client’s team as a Label Development Specialist in Ridgefield, CT. The Label Development Specialist role s responsible for the planning, monitoring, and execution of labeling activities in support of global clinical trials (Phases I-IV). This role requires effective communication and negotiation with various stakeholders to ensure the timely provision of Investigational Medicinal Product (IMP) labels. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES
• Label Text Review: Autonomously review Master Label Text drafts, ensuring compliance with regulatory requirements, standard phrases, and trial-specific details.
• Preparation of Label Text: Prepare country-specific label text for translation, ensuring accuracy and compliance with local regulations.
• Translation Review: Review and check translated label text for adherence to local requirements.
• Proof Review: Review generated print proofs and distribute them to respective countries for verification and approval.
• Collaboration: Work closely with global Trial Teams, Regulatory Affairs, Medicine, and label vendors to define and optimize labeling tasks.
• Timeline Management: Ensure that all packaging and labeling vendors adhere to timelines, providing the global trial team with updates on milestones.
• Documentation Compilation: Compile and provide complete label documentation for final release to the Release and Process Management Team.
• Vendor Liaison: Act as the primary contact for external vendors and countries, addressing questions and ensuring effective communication throughout the labeling process.

EXPERIENCE
• Background in clinical trials, with a focus on supply chain, clinical trial regulations, and packaging and labeling.
• Thorough understanding of clinical supply chain activities and applicable regulations (e.g., CTR 536/2014).

EDUCATION
• Master’s Degree in a related field or equivalent professional training with extensive experience.

To be a best-fit your strengths must include:
• Strong project management abilities.
• Proficient in interpreting standard and complex project requirements.
• Excellent problem-solving, risk assessment, and troubleshooting skills.
• Ability to work independently and collaboratively in a global team environment.
• Proficient in Microsoft Office and other relevant software.
• Fluency in English is required.