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Student Assistant to support CS Trial Setup (part time) - Denmark  

Company managed [?] Still accepting applications

Posted on : 15 April 2017

Project Description


Job Description
  • Are you looking for new challenges? 
  • Would you like to join a rapidly growing part of our company's R&D organisation by creating printed packaging materials together with a dedicated team of colleagues? 
  • As part of our company's R&D family, CMC Development makes a real difference for patients with chronic diseases across the world.
  • We develop, manufacture and distribute drug candidates for non-clinical and clinical trials which is a complicated journey that requires about 10 years of dedicated work in CMC Development.
  • CMC Development is an ambitious organisation with a strong culture. 
  • We always seek to solve problems, have an eye for the entire business and do our best to deliver despite any obstacles along the way.



About the department
  • Clinical Supplies Trial Setup (CSTS) is a department in CMC Clinical Supplies, the area responsible for filling, planning, packing and delivering supplies for all clinical trials in our company.
  •  CSTS prepare the trials for execution by reviewing the trial protocol, creating the printed packaging materials and preparing the master data needed for the packaging department. 
  • We support all clinical trials conducted globally by our company and operate in the combined field of supply chain management and regulatory requirements within drug development.
  •  Our department consists of 3 teams: Trial Set-up Planning, Label & DFU Set-up and Trial Master Data



The position
  • The position is in the Label and DFU Team (LDS), where labels and directions for use are prepared, translations coordinated, and approvals by our affiliates world-wide are coordinated. 
  • Labels and DFUs are submitted to local health authorities before initiating a clinical trial, and timeliness is of utmost importance to ensure the trials can start on time.
  • The role as a student assistant (part time) in CSTS-LDS involves reviewing documents and labels/DFUs, coordinating with affiliates and vendors, archiving and supporting all the teams in CSTS with ad hoc tasks. Expected work time is 2 days per week.


Qualifications
  • We are looking for someone who is engaged, systematic, service minded and outgoing with a high sense of detail and responsibility. 
  • You have a strong quality mind-set, communicate effectively, meet deadlines, and approach tasks in a structured way. 
  • You have excellent computer skills and are not afraid to learn new systems. 
  • Finally you must be fluent in written and spoken English.


Working with Us:
  • Your skills, dedication and ambition help us change lives for the better
  • In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.