Regulatory Scientific Writer Position
We are seeking a skilled Regulatory Scientific Writer to join our Global Scientific Communications team on a permanent basis.
* About the Role:
o The ideal candidate will plan, write, edit, and finalize regulatory documents ensuring data accuracy, clarity, and consistency while coordinating reviews and incorporating feedback.
o Project management responsibilities include developing timelines, managing risks, tracking progress, and maintaining communication with stakeholders to deliver on schedule.
o Maintain up-to-date knowledge of assigned therapeutic areas, compounds, and relevant regulatory guidelines.
o Collaborate and coach colleagues by sharing best practices and providing guidance contributing to process improvements.
Key Responsibilities:
* Document Development: Create high-quality regulatory documents following strict guidelines.
* Project Management: Develop project plans, manage resources, and track progress to ensure timely delivery.
* Scientific Expertise: Stay updated on industry developments, regulatory changes, and scientific advancements.
* Cross-Functional Collaboration: Work closely with cross-functional teams to achieve common goals.
Requirements:
* Bachelor's degree in life sciences, health, communications, or related field.
* Advanced degree with research background is preferred.
* 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
This role offers hybrid working arrangements. The company is a global pharma organization located in Cork, Ireland.