Regulatory Review Coordinator, Ogilvy Health

Ogilvy Health USParsippany, NJ
$40,000 - $85,000

About The Position

We are looking for a Regulatory Review Coordinator to join our agency to assist in preparing, submitting and tracking MLR (Medical, Legal and Regulatory) submissions across our book of pharmaceutical clients. The ideal candidate is detail-oriented, highly accountable, and eager to learn the ins and outs of FDA regulations and the healthcare communications industry.

Requirements

  • One year of transferable work experience in a related field.
  • Self-motivated, highly organized, and detail-oriented with excellent time management skills.
  • Ability to work effectively both independently and collaboratively to meet deadlines.
  • Excellent written and verbal communication skills.

Nice To Haves

  • Experience with Veeva Vault platform preferred.

Responsibilities

  • Assist in the assembly and delivery marketing materials for regulatory review following the protocols established by our pharmaceutical clients.
  • Digitally route submission packages to internal team, facilitating communication cross-functionally.
  • Handle multiple projects with different teams concurrently in a timely manner.
  • Assist in maintaining departmental archives and documentation.
  • Attend client-led trainings on submission platform requirements.
  • Complete medical reference tagging & linking in Veeva Vault or other client software tools.
  • Work closely with the Project Management team to ensure smooth transition of files and accurate project timelines.

Benefits

  • We offer a competitive benefits package
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