Principal Medical Writer

Global pharmaceutical company is looking for a Principal Writer to join their tight-knit regulatory medical writing team in their NJ office. The writer will be engaged in clinical and submission document writing and project management. A competitive salary and benefits package are offered, and this position allows for some work-from-home flexibility!

Responsibilities:

-Write clinical regulatory documents including protocols, CSRs, IBs, clinical sections of IMPDs and CTDs (Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview)
-Manage/mentor internal and remote writers in the preparation of documents
-Ensure the quality, compliance with internal and external standards, and timely and efficient production of clinical documents
-Contribute to submission strategy and timeline planning

Requirements:

-Must be an independent, proactive, experienced medical writer with the ability to analyze data for the preparation of documents (Minimum 5 years experience)
-B.A. in a scientific discipline required, M.A. and PhD desirable
-Experience in diabetes is desirable, but not required
-Demonstrated leadership in preparing multiple key summary submission documents
-Demonstrated experience managing the project work of other medical writers
-Manage timelines, meet deadlines, problem solve, negotiate, mentor
-Ability to coordinate cross-functionally with study teams

This is a rare opportunity to join an excellent writing team at a large pharmaceutical company and immediately step into a leadership role. Don't miss out! Apply today and send resumes to Jess Lakis. (tel: 212-707-8499)
To find out more about Real please visit www.realstaffing.com