Clinical Operations

  • location: Parsippany, NJ
  • type: Contract
  • salary: $40.38 - $47.50 per hour
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job description

Clinical Operations

Job Title: Label Review Contractor

Job Responsibilities

  • Provide Regulatory Support for Current Products and Development Projects
  • Execute strategy and provide regulatory support.
  • Deliver projects and other initiatives to progress current product portfolio by providing regulatory direction and support to stakeholders:
  • Review product labeling and supporting materials.
Implement New Regulations and Guidances

  • Work with stakeholders to implement requirements within specified timelines.
  • Assess and communicate all requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues.
  • Adjust and monitor timelines to support the business.
Support Infrastructure and Systems Integration

  • Deliver project and brand specific activities assuring they are correct, complete and on-time including registrations, submissions, labeling/advertising initiation/reviews, etc.
Education & Qualifications

  • BA/BS degree required in the natural sciences.
  • A minimum of 3 years of relevant work experience required (including proofreading).
  • Experience with FDA registered products is preferred.
  • High attention to detail and strong organization skills
  • Ability to establish close communications and working relationship with cross functional teams to meet business objectives
  • Strong verbal and written communication skills and interpersonal skills.
  • Results oriented, entrepreneurial and self-motivated
  • Excellent computer skills (Microsoft Office suite)
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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