Regulatory Document Writer
2 weeks ago
This is a permanent role involving the creation of high-quality regulatory documents. As a Regulatory Document Writer, you will be responsible for planning, writing, editing, and finalizing these documents. You will also ensure data accuracy, clarity, and consistency, as well as coordinate reviews and incorporate feedback.
Main Responsibilities:- Document Development: Plan, write, edit, and finalize regulatory documents to ensure data accuracy, clarity, and consistency.
- Project Management: Develop timelines, manage risks, track progress, and maintain communication with stakeholders to deliver on schedule.
- Scientific Expertise: Maintain up-to-date knowledge of assigned therapeutic areas, compounds, and relevant regulatory guidelines.
- Collaboration & Coaching: Share best practices, provide guidance to colleagues, and contribute to process improvements.
- Bachelor's degree in life sciences, health, communications, or related field.
- Advanced degree with research background.
- Expertise in relevant therapeutic areas (e.g., oncology, neuroscience, immunology)
- Experience with clinical development and regulatory submissions
- Proven experience in regulatory or technical scientific writing
- Strong communication, interpersonal, and project management skills
- Proficiency with document management systems and standard software tools
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