AD Or Director Of Medical Writing

Global pharmaceutical company inNew Jerseyis seeking an Assistant Director or Director of Medical Writing to lead high profile submissions. 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 documents for regulatory submissions, including NDAs, INDs, CSRs, IBs, ISS, ISE, dossiers, etc.
-Participate heavily in submission timeline and planning
-Ensure the quality, compliance with internal and external standards, and timely and efficient production of clinical documents
-Manage contractors and mentor in-house writers in the preparation of documents
-Work closely across functional teams to accomplish goals within set deadlines

Requirements:

-Minimum 8 years of medical writing experience
-Demonstrated leadership in preparing multiple key summary submission documents (ie. serving as the lead writer)
-Minimum of BS, advanced degree such as MS, PhD, PharmD, or BSN is preferred
-Must be able to manage timelines, meet deadlines, problem solve, negotiate, mentor
-Ability to coordinate cross-functionally with study teams
-Excellent communication skills

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 on the chance to lead a close-knit writing group and spear head some of the most exciting new submission projects in the industry! Send resumes to Jess Lakis. (tel: 212-707-8499)
To find out more about Real please visit www.realstaffing.com