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Regulatory Medical Writing Director
1 week ago
We're a leading manufacturer of generic medicines, proud producer of many products on the World Health Organization's Essential Medicines List. Our mission is to make good health more affordable and accessible, helping millions around the world enjoy healthier lives.
The OpportunityAs Senior Director in Global Regulatory Medical Writing & Data Transparency, you'll provide leadership, direction, and competence to a team of medical writers/managers and electronic document specialists within Clinical Specialty Development. Your goal will be to produce high-quality clinical research documentation that adheres to departmental standards and regulatory guidelines, supporting drug development, product registrations, and product marketing to meet our global strategic, scientific, regulatory, and commercial goals.
You will:
- Offer clear leadership and extensive accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.
- Serve as a liaison among internal/global functional groups to ensure optimal use of resources in making medical writing support available for all projects.
Mentoring and proficiency will also be key aspects of your role, providing guidance to manager-level direct reports.
This is a hybrid opportunity that can be based out of our Parsippany, NJ or West Chester, PA offices.