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Regulatory Writer I

3 months ago


Oxford, Oxfordshire, United Kingdom Certara Full time

Overview:

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:

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 projectrelated meetings
  • Participate in comment resolution meetings, complete appropriate preparation documents, and compile appropriate followup responses
  • Understand and adhere to constraints of budgets and tasks as provided by project leads

Qualifications:

Education, Experience, Training, and Knowledge:

  • Bachelor's degree or higher, scientific discipline strongly preferred
  • Strong computer skills, including proficiency with Microsoft Word and the Microsoft Office Suite

Skills & Abilities:

  • 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