Regulatory Writer I

Overview

About Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries

Regulatory Writers provide support on the development of high‑quality documentation for regulatory submissions to help streamline the regulatory documentation process for our clients. The Regulatory Writer I (RW I) will support senior writers in the creation of a variety of documents across different service lines. The RW I will provide scientific insight and analysis while developing a broad scientific knowledge base in the pursuit of a successful project.

Responsibilities

• Participate on project teams that may be led by a Principal Regulatory Writer, an Associate Principal Regulatory Writer, or a Senior Regulatory Writer
• Author documents or sections of documents per client specifications, templates, style guides, and other guidance documents under the direction of a senior writer
• Usher documents through the review process
• Participate in project-related meetings
• Participate in comment resolution meetings, complete appropriate preparation documents, and compile appropriate follow-up responses
• Understand and adhere to constraints of budgets and tasks as provided by project leads
  
  

• Bachelor’s degree or higher, scientific discipline strongly preferred
• Strong computer skills, including proficiency with Microsoft Word and the Microsoft Office Suite
• Demonstrate effective written and verbal communication skills
• Demonstrate understanding of analyzing data and presenting them in a written format
• Ability to work in a collaborative environment, be tolerant of differences in culture and beliefs, and easily build relationships with others
• Action and detail oriented, always seeking new development opportunities to build knowledge and skills
• Demonstrate solid time management and other organizational skills
• Show flexibility to meet project needs as required by deadlines and meet corporate goals and objectives
• Remain knowledgeable of changes in the industry and adapt best practices