R&A- Senior Regulatory Writer- SRW (Clinical focus)

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines.

Requirements

• Lead a project team or participate in a project team
• Author documents per client specifications, templates, style guides, and other guidance documents
• Act as client advisor, working with all parties to lead development of strategies for organizing and preparing regulatory documents
• Manage hours for their projects, including all contributors (writers and editors)
• Usher documents through the review process, lead comment resolution meetings, and successfully lead a project team to consensus
• Maintain collaborative, proactive, and effective communication with both client and internal teams
• Lead or participate in project-related meetings
• Provide coaching to junior staff for study-level documents