Regulatory Writing Manager
The Judge Group Inc.
Job Info
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
- 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
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