Please send your application to Recruiter.China@catalent.com.
Specific Duties, Activities, and Responsibilities:
· Prepare, coordinate, design and generate clinical study labels and commercial labels.
· Prepare, coordinate, upload and generate randomization codes for use in clinical studies.
· Perform above functions using the electronic labeling system (PMX or Clinicopia). Verify all information conforms to GMP, Annex 13, customer and Catalent regulatory requirements.
· Summarize and visualize the structure of package and label needed for clinical study to prepare for in-house label printing.
· Design or reorganize the layout of client-provided label text if needed to adjust the label stock.
· Support project management and clients regarding label design and timeline of in-house printing.
· Generate randomization code in Clinicopia if needed.
· Upload, maintain and keep record of randomization code for study in JDE.
Position Requirements:
· Bachelor’s degree in Science/Engineering or above.
· 1+ Years of clinical supplies preferred.
· Knowledge and experience with cGMP, Annex 13, EU and FDA regulations desirable.
· Strong logical thinking can obtain a concept of the whole study and package.
· Good in written English, CET 6 or above (please provide the score), candidate with overseas experience preferred.
· Fluent in Microsoft Office, Excel a must.
· Obtain both good oral and written communication skills.
· Organized, self-motivated, goal-oriented and willing to learn.
· Customer service oriented with a team-player attitude.
· Ability to work independently.