Regulatory Labeling Associate / Change Control Assistant

Job Description

POSITION SUMMARY:

This position is to support the Global Labeling Centre of Excellence (GL COE) Global Labeling Compliance (GLC) group with maintenance of labeling change control records within the TrackWise system to improve data quality and ensure timely completion of milestones.

Principle Responsibilities may include:

Correct change control records in the Trackwise system, in accordance with direction provided by GLC colleagues, following naming conventions and according to required timelines.

Set up and run reports in the Trackwise system to assess data completeness of the records.

Manipulate data in MS Excel to identify gaps and issues based on business rules.

Required Technical Competencies & Knowledge:

A minimum of 2 years experience in a highly regulated environment (pharmaceutical, etc.) required.

Prior change control management experience (i.e., administration, execution) preferred.

Knowledge of and experience in the ETS Trackwise Change Control environment or equivalent preferred.

MS Excel skills and comfort with MS Office and Sharepoint.

Effective interpersonal, verbal and written communication skills, in English.

Maintains confidentiality and meets own commitments.

Completes work in a timely, error-free, and consistent manner.

Qualifications

high school diploma or higher

Additional Information

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960