Regulatory Document Writer
We are seeking a skilled Regulatory Document Writer to join our team. As a key member of our Global Scientific Communications team, you will be responsible for creating high-quality regulatory documents throughout the drug development lifecycle.
Key Responsibilities:
* Plan, write, edit, and finalize regulatory documents to ensure data accuracy, clarity, and consistency.
* Develop timelines, manage risks, track progress, and maintain communication with stakeholders to deliver on schedule.
* Maintain up-to-date knowledge of assigned therapeutic areas, compounds, and relevant regulatory guidelines.
* Share best practices, provide guidance to colleagues, and contribute to process improvements.
Requirements:
* Bachelor's degree in life sciences, health, communications, or related field.
* Advanced degree with research background preferred.
* Expertise in relevant therapeutic areas, such as 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.