Sr. Regulatory Writer

The Senior Regulatory Writing Specialist partners directly with Global Regulatory connects and supports project teams across multiple compound and/or projects to ensure the development of high-quality, message-focused, submission-ready, regulatory documents. The incumbent is responsible for the preparation of key regulatory documents for submission to global Health Authorities. This role is expected to exhibit organizational and project management skills consistent with level and to work cross-functionally with a high degree attention to detail and prompt response in a fast-paced work environment.

Principal Responsibilities

• Plans, writes, edits, and reviews clinically focused regulatory documents such documents include, among others, briefing documents, Common Technical Document Module 2 clinical-focused documents and Module 5 integrated summaries, pediatric study plans, and Health Authority responses.
• Ensures document quality regarding agreed upon key messages, compliance with Standard Operating Procedures (SOPs) and Health Authority guidance, and consistency with applicable style guides and document conventions
• Collaborates with document authoring teams/Module sub-teams/Dossier Teams to establish document key messages, timelines, and priorities
• Conducts document kick-off meetings, participates in timeline planning, and facilitates cross-functional document development as ad hoc member of Global Regulatory Project Teams
• Manages review and approval workflows in the electronic document management system (EDMS)
• Develops processes and SOPs for Regulatory Writing
• Provides input into resource forecasting for projects; establishes vendor requirements for Regulatory Writing needs; and oversees vendors providing regulatory writing services when applicable.
• Provides guidance to project team members unfamiliar with or inexperienced in regulatory document requirements