Associate Director of Medical Writing Jobs NEW JERSEY-CENTRAL
Global biopharmaceutical company is seeking an associate director of medical writing in New Jersey to be in charge of regulatory writing. Salary level is extremely attractive and you will be instrumental in setting up a new department!
Responsibilities:
- Development and management of direct reports and outsourcing plans for medical writing in assigned product areas
- Co-develop the strategy for document preparation, SOPs, and guideline documents including time frames that meet or exceed company standards and the document review processes
- Prepare content templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines
- Leading Phase I-IV clinical and regulatory documents and submissions, including IBs, CSRs, integrated summaries of efficacy and safety, registration dossiers, package inserts, briefing books, and responses to health authorities
- Manage, train, mentor and work closely with other writers (direct reports or contractors)
Requirements:
-MS, MD, PhD preferred, Min of BS
-Knowledge of FDA and ICH guidelines
-Extensive experience writing all types of clinical regulatory documents
This company has a great pipeline and excellent working environment with friendly, open and excellent communication - people are happy here with an excellent work-life balance!
Send all resumes today to Dandan Zhu at Real Pharma - 212-707-8499
Many other excellent regulatory writing roles available!