Dallas Texas /

Responsibilities:

• Excellent employment opportunity for a Packaging and Labelling Specialist in the Ridgefield, CT area.
  
• Responsible for managing and performing tasks along the Clinical Trial Supply Chain, especially related to packaging and labelling of investigational medicinal products (IMPs).
  
• Responsible to perform and document tasks in compliance with regulations, policies and industrial need.
  
• Information provision and ordering: packaging design, as well as planning, monitoring and controlling the packaging and labeling orders, as well as filling of related GMP documents.
  
• Responsible to ensure and support timeline and quality of clinical supplies, as well as cost efficiency and risk assessment, safety culture and lean business.
  
• Continuous improvement/innovations: management of packaging and labelling tasks of IMPs at external vendors for assigned projects and clinical trials.
  
• Create and optimize workflows and processes with vendors and partners as well as packaging & labelling group.
  

Experience:

• Master's Degree or Bachelor's Degree with experience in a related field or professional training with extensive experience in a related field.
  
• Skills Background in Clinical Trials (Supply Chain, Clinical Trial Regulations, Packaging and Labeling area, medical documentation).
  
• Experience with packaging and labeling needs & processes such as Food and Pharmaceutical industries.
  
• Demonstrates knowledge of all areas of clinical supply chain activities and a thorough knowledge and understanding of applicable US and EU regulations.
  
• Solid Project Management skills.
  
• Ability to interpret standard and complex project requirements.
  
• Strong problem solving, risk assessment and troubleshooting skills.
  
• Good knowledge and understanding of applicable regulations.
  
• Work independently and in a team environment.
  
• Required Skills: PACKAGING, SUPPLY CHAIN