As a seasoned medical writer, you will play a pivotal role in crafting high-stakes clinical regulatory documents that drive the success of our partner's strategic projects.
About This Opportunity
We are seeking an experienced medical writer to lead the development of complex clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures, for submission to regulatory authorities worldwide.
Your Key Responsibilities
* You will work closely with our partner's team as an embedded expert contributor.
* You will leverage your expertise to write, advise, and coordinate the development of clinical regulatory documents, ensuring compliance with global regulatory requirements.
Requirements
* Advanced degree (PhD or Masters) in a relevant field.
* Minimum 6 years of experience in eCTD submission writing, including 3 years as a medical writing project lead.
* Proven track record of leading content development for efficacy or safety clinical summary modules and drug applications across different regions.
A Unique Career Opportunity
This is a chance to take control of your career path, shape your own development, and thrive in a dynamic environment where science meets innovation.
* If you're passionate about medical writing and want to remain deeply involved in science, this opportunity is ideal for you.
* If you're looking to transition into management, we offer comprehensive training and support to prepare you for leadership roles.