Regulatory Project Manager and Filing Expert
14 hours ago
Proclinical is seeking a dedicated and experienced Regulatory Project Manager and Filing Excellence Consultant to join our team. This role will focus on developing and implementing best practices for preparing major global regulatory filings.
Key Responsibilities:- Project management for late-stage global regulatory filings.
- Develop and optimize detailed regulatory project plans and timelines in collaboration with various teams.
- Maintain project dashboard for sharing progress and risks with senior management.
- Identify and highlight project interdependencies.
- Coordinate lessons learned sessions and ensure implementation of feedback for process improvement.
- Bachelor's degree in a scientific or medical field.
- Demonstrated project management skills with the ability to prioritize multiple projects.
- Experience developing project plans, content plans, and other filing tools.
- Proficiency in Smartsheet, MS Project, Visio, Excel, Veeva, SharePoint.
- Excellent organizational and meeting management/facilitation skills.
- Experience with regulatory filings, original NDA/BLA/MAA and response to questions is a plus.
This is an exciting opportunity to join a dynamic team and contribute to the success of Proclinical. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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