Location: Ridgefield, CT
Duration: 01/06/2025 - 12/31/2026
Schedule: Full-time, 40 hours/week
Are you ready to bring your expertise in clinical labeling and project management to a high-impact role supporting global clinical trials? Our client is seeking a Label Development Specialist to drive the labeling process for Phase I-IV clinical trials. This role is central to ensuring the timely, compliant, and high-quality provision of IMP labels across global studies.
Key Responsibilities:
- Lead the end-to-end label development process, including drafting, preparing, and reviewing Master Label Text and country-specific label text.
- Collaborate with global Trial Teams, Regulatory Affairs, and external vendors to optimize labeling workflows and meet trial-specific requirements.
- Review and validate translated label text for regulatory and local compliance, ensuring accuracy and adherence to standards.
- Oversee label milestone tracking and maintain clear, effective communication across teams, supporting efficient project progression.
- Serve as the primary contact for all label-related inquiries, coordinating with vendors and countries.
Skills & Qualifications:
- Master's Degree in a relevant field, or equivalent professional experience.
- Strong background in clinical trials, specifically in labeling, supply chain, and clinical trial regulations.
- Exceptional project management and problem-solving abilities, with a proactive approach to managing timelines and risks.
- Knowledge of clinical supply chain regulations (e.g., CTR 536/2014).
- Proficiency with Microsoft Office and excellent communication skills.
This role is an exciting opportunity to contribute to impactful global studies, ensuring that labeling activities meet the highest standards and timelines. If you have a passion for project management and a commitment to excellence, we encourage you to apply!