Transformative Medical Writing Leadership Opportunity
About the Role
We are seeking an experienced and accomplished medical writer to lead the development of high complexity clinical regulatory documents. As a key member of our global project teams, you will work closely with stakeholders to drive document development and ensure timely submission.
This role offers a unique opportunity for career growth and professional development. With comprehensive training and support, you will be equipped to take on leadership roles and shape your own career path.
Responsibilities
* Develop and manage complex clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures.
* Collaborate with project teams to develop and implement document development strategies.
* Provide expert guidance on clinical regulatory document development and submission.
* Maintain up-to-date knowledge of clinical regulatory requirements and best practices.
Requirements
To succeed in this role, you will need:
* Advanced degree (PhD or Masters)
* Minimum 6 years eCTD submission writing experience, including 3 years as medical writing project lead.
* Experience and proficiency in writing and leading development of a variety of clinical regulatory medical writing deliverables.
* Proven experience leading stakeholders/project teams through submission document development.
Career Development Opportunities
At [Company], we believe in empowering our team members to shape their own career paths. This role offers comprehensive training and support to help you grow professionally and take on new challenges.
We are committed to creating a collaborative and dynamic work environment that fosters personal growth and achievement.