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