Job Title: Scientific Writer Regulatory
A key role for a skilled Scientific Writer Regulatory is available in a global pharma company's Global Scientific Communications team. This permanent position involves creating high-quality regulatory documents and collaborating with cross-functional teams.
About the Role
The successful candidate will be responsible for planning, writing, editing, and finalizing regulatory documents such as clinical study reports, briefing packages, and IND/MAA submissions. Ensuring data accuracy, clarity, and consistency is crucial, along with coordinating reviews and incorporating feedback.
This role offers hybrid working arrangements, allowing for flexibility and work-life balance.
Responsibilities
* Document Development: Plan, write, edit, and finalize regulatory documents to ensure data accuracy, clarity, and consistency. Coordinate reviews and incorporate feedback.
* 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.
Requirements
* Bachelors 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.