Remote Regulatory Writing Director

Job ID: Available for Members

Location: Massachusetts

Compensation: To Be Discussed

Staff Reviewed: Mon, Feb 18, 2019

This job expires in 27 days

Job Category: Healthcare, Legal, Management

Telecommute Level: Majority

Travel Requirements: Possible Travel

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Senior Level

Job Summary

A pharmaceutical consulting company is in need of a Remote Regulatory Writing Director.

Individual must be able to fulfill the following responsibilities:

  • Understand, interpret and influence regulatory requirements such as: National Regulatory agencies
  • Provide regulatory compliance guidance and decision making for the company in order to be fully compliant
  • Hire, retain and develop qualified personnel, as well as resolving all personnel issues

Position Requirements Include:

  • Demonstrated management/supervisor related experience
  • Excellent leadership and management abilities
  • Good working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
  • Ability to effectively train and educate internal staff on procedures and regulatory issues
  • Demonstrated ability to develop effective procedures and to write clear, consistent, thorough SOP's
  • All other requirements necessary for this position