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.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.