Remote Senior Submission Operations Associate

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Sun, Jul 19, 2020

This job expires in 9 days

Job Category: Healthcare, Information Technology

Telecommute Level: Majority

Travel Requirements: Field Travel Required, Some Travel

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Job Summary

A biotechnology research company is in need of a Remote Senior Submission Operations Associate.

Core Responsibilities of this position include:

  • Acting as lead publisher when required, for major applications
  • Supporting Regulatory Affairs to deliver high quality and consistent maintenance health authority submissions
  • Assisting in the evaluation, implementation or upgrade of software

Skills and Requirements Include:

  • Travel as required (Approximately 10%)
  • A minimum of 3-5 years in the biotechnology or pharmaceutical industry
  • Regulatory operations experience within a regulated environment with experience and knowledge
  • Experience using eCTD compliant publishing system
  • Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness