clinical operations in parsippany

posted
job type
contract
salary
US$ 40.38 per hour
apply now

job details

posted
location
parsippany, new jersey
job category
Biotechnology & Pharmaceutical
job type
contract
salary
US$ 40.38 per hour
reference number
25704
apply now

job description

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.