Clinical Operations

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $63.69 - $74.93 per hour
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job description

Clinical Operations

Job Title: Labeling Manager

Job Summary

  • The purpose of the position is to update corporate (CCDS), US and EU labeling (prescribing information and patient information) documents for mature and marketed products to obtain company and/or agency approval, under the supervision of labeling management.
  • Development of labeling for these products is based on study results, coordination of labeling review and approval throughout the company, and preparation of labeling components for submission to regulatory agencies.
  • The position also includes review of local labeling to assure compliance with corporate labeling.
Education & Qualifications

  • Bachelor's degree in Life Sciences or medically-related field. Minimum of one year experience in the pharmaceutical industry and three or more years in work experience.
  • This position requires 1-3 years of Labeling Content and Strategy experience. Manager specified this is not for an operations or packaging person.
  • Experience with writing/updating Company Core Labeling (CCDS).
  • Medical/pharmacy/science background
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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