Senior Scientific Writer - (Princeton, NJ)

Responsibilities: 1. Coordinate and author documents needed for regulatory submissions (eg, IBs, Phase 2/3 CSRs, briefing documents, CTD summary documents), ensuring the coordination and integration of the scientific, medical, and regulatory input from development teammates. 2. Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents. 3. Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. 4. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent teammates to ensure timely completion and high-quality of assigned documents. 5. Review and edit documents as required. 6. As required, coordinate writing of responses to Health Authority questions. Education, Background, Skills: 1.