Job Description
Responsibilities
- Author regulatory documents including Clinical Study Reports (CSRs), study protocols, and client submission materials
- Lead development of complex modules such as Module 2 summaries and Briefing Documents
- Manage applications for Orphan Drug, Fast-Track, and Breakthrough Designations
- Apply quality control and submission-readiness processes to ensure high-quality deliverables
- Act as project owner by tracking timelines, adjusting schedules, and coordinating with clients
- Facilitate client interactions, including meetings and feedback discussions
- Collaborate with cross-functional teams to ensure document accuracy and alignment with regulatory standards
- Provide guidance on document management systems and client SOPs
Requirements
- 3+ years of industry experience
- Proficiency in Microsoft Office Suite, Teams, and MS Project
- Familiarity wi...