Regulatory Writing Manager at The Judge Group Inc. in Miami, Florida

Job Description:

Location: REMOTE

Salary: $25.00 USD Hourly - $49.00 USD Hourly

Description: Our client is currently seeking a Regulatory Writing Manager


Must Haves:

In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.



This job will have the following responsibilities:

• 5+ years in writing clinical and regulatory documents


• Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment


• Ability to analyze medical data and interpret its significance


• Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance

Qualifications & Requirements:

• Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)


• Lead study timelines for regulatory documents and regulatory submission strategy


• Act as a functional area representative and lead on product teams


• Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance


• Ensure quality of regulatory submission documents at all stages of development
  
  

Contact: asheikh@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com Apply Now