R&a - Regulatory Writer I

1 week ago

Remote, United Kingdom Certara Full time

Overview:
Regulatory Writers provide support on the development of high quality documentation for regulatory submissions in order 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. On occasion, the RW I may lead a simple project if considered appropriate.

**Responsibilities**:
**Responsibilities**:

- Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or 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 (CRMs), complete appropriate preparation documents, and compile appropriate follow-up 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 in a scientific discipline
- Strong computer skills, including proficiency with Microsoft Word and the Microsoft Office Suite

**Skills & Abilities**:

- Demonstrates effective written and verbal communication skills
- Demonstrates understanding of analyzing data and presenting in a written format
- Ability to work in a collaborative environment and be tolerant of differences in culture and beliefs, 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

**Locations**: Office or remote-based: UK, Netherlands and Germany

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