标签控制专员 - 临床药品

该职位来源于猎聘 SUMMARY OF ESSENTIAL FUNCTIONS: 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. SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Summarize and visualize the structure of package and label needed for clinical study to prepare for the upcoming 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: Strong logical thinking and can obtain a concept of the whole study and package. Good in written English, CET 4 or above. Fluent in Microsoft Office, Excel a must. Obtain both good oral and written communication skills. Organized, self-motivated, goal-oriented and willing to learn. Knowledge and experience with cGMP, Annex 13, EU and FDA regulations preferred. Customer service oriented with a team-player attitude. Ability to work independently. EDUCATION OR EQUIVALENT: Bachelor’s degree preferred. EXPERIENCE: 1 Years of Clinical Label Supplies Experience preferred.