Scientific Writer Regulatory
Our client, a global pharma company, are currently growing their Global Scientific Communications team and are currently seeking a skilled Scientific Writer Regulatory to join their team on a permanent basis. As Scientific Writer Regulatory you will be responsible for the creation of high-quality regulatory documents (e.g., clinical study reports, briefing packages, regulatory responses, IND/MAA submissions). The role involves collaborating with cross-functional teams to ensure clear, accurate, and compliant scientific content throughout the drug development lifecycle. This role offers hybrid working.
Responsibilities:
1. Document Development: Plan, write, edit, and finalize regulatory documents; ensure data accuracy, clarity, and consistency; coordinate reviews and incorporate feedback.
2. Project Management: Develop timelines, manage risks, track progress, and maintain communication with stakeholders to deliver on schedule.
3. Scientific Expertise: Maintain up-to-date knowledge of assigned therapeutic areas, compounds, and relevant regulatory guidelines.
4. Collaboration & Coaching: Share best practices, provide guidance to colleagues, and contribute to process improvements.
Requirements:
5. Bachelor's degree in life sciences, health, communications, or related field.
6. Advanced degree with research background.
7. Expertise in relevant therapeutic areas (e.g., oncology, neuroscience, immunology)
8. Experience with clinical development and regulatory submissions
9. Proven experience in regulatory or technical scientific writing
10. Strong communication, interpersonal, and project management skills
11. Proficiency with document management systems and standard software tools
For more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie