Regulatory Writing Manager
The Judge Group Inc.

Job Info

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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

This job has expired.