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Labeling Associate
Ref No.: 18-05859
Location: Princeton, New Jersey
Start Date / End Date: 09/04/2018 to 09/06/2019
Department: 160610 : PD D&R Admin EH
Sandoz Inc.
Job Category: Administrative
Job Code:
Job Title: Labeling Associate
Keywords:
Number of Positions: 1
Remaining Positions: 1
Duties:

Job Description: Prepare, review, approve and manage labeling for pharmaceutical products for FDA submission in accordance with FDA regulations.


RESPONSIBILITIES
• Responsible for the creation of pharmaceutical labeling drafts for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Sandoz requirements.
• Responsible for the creation of labeling in SPL and PLR format.
• Responsible for working with outside vendors for creation of labeling proofs and ensuring accuracy of final labeling.
• Responsible for managing and tracking the review process for labeling pieces to ensure timely submissions to FDA.
• Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements.
• Responsible for maintenance of all labeling files in accordance with internal procedures

Skills:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Ability to work under tight deadline pressure and handle multiple projects.

• Must have ability to take and follow directions. Familiarity with FDA Labeling guidelines (21 CFR) required.

• Must possess excellent communication and organizational skills, be a team player and have a meticulous eye for details.

EXPERIENCE

5-8 Years Pharmaceutical Labeling Experience

KNOWEDGE

SPL, Word, Excel, PowerPoint

Education:

Minimum BA degree

Languages:
English Read Write Speak
Attachments:
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Skills:

Required

  • FDA
  • MAINTENANCE
  • ORGANIZATIONAL SKILLS
  • TEAM PLAYER
  • USP

Additional

  • EXCEL
  • MICROSOFT EXCEL
  • MICROSOFT POWERPOINT
  • MICROSOFT WORD
  • POWERPOINT
  • WORD
Languages: English( Speak, Read, Write )
Minimum Degree Required:
Also Preferred:
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Work Performed
Onsite:
State/Province: New Jersey
City/Town: Princeton
Address: 100 College Road West
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Start Date: 09/04/2018 Hours Per Week: 40.00
Est. End Date: 09/06/2019 Hours Per Day: 8.00
Schedule Notes: Days Per Week: 5.00