Job Title: Medical Writer Lead
As a key member of our team, you will play a crucial role in creating, reviewing and managing clinical and regulatory documents.
Responsibilities
* Develop, write and edit complex clinical and regulatory documents including clinical study reports, protocols, investigator brochures and regulatory submissions.
* Collaborate with cross-functional teams to ensure accurate and timely completion of documents.
* Ensure documents align with regulatory guidelines, industry standards and company best practices.
* Provide strategic input and guidance on document content, structure and presentation.
* Mentor junior medical writers and oversee deliverables.
Requirements
* Bachelor's degree in a scientific discipline or equivalent and relevant formal academic qualification required. Advanced degree preferred.
* Regulatory writing experience providing knowledge, skills and abilities to perform the role (comparable to 8+ years).
* Experience working in pharmaceutical/CRO industry required.
* EU CTR experience preferred.
What We Offer
We offer a competitive salary and extensive benefits package based around employee health and well-being. A flexible working culture is valued where work-life balance is prioritized. Our organization has grown sustainably year on year but continues to offer a collaborative environment with colleagues eager to share expertise and have fun together.