Principal Medical Writer

Global biopharmaceutical company is seeking a Principal Medical Writer inNew Jerseyto write clinical and submission documents, develop submission strategy, and generally lead regulatory writing efforts. The company is looking to add an experienced regulatory writer to the tight-knit writing team in theNew Jerseyoffice.

This is a brand new position that has opened up due to exciting expansion of the drug pipeline in the company's leading therapeutic areas.

Responsibilities:

- Management of medical writing projects, regulatory documents, timelines, and key document writing.
- Write phase I-III clinical and regulatory documents and submissions including IBs, CSRs, ISS's & ISE's, NDA's, IND's, clinical overviews, protocols, registration dossiers, package inserts, briefing books, and responses to health authorities
-Lead submissions
-Manage, train, mentor, and work closely with other writers

Requirements:

-5+ years of solid medical writing experience is REQUIRED. Please do not apply if you do not have experience writing regulatory documents.
-BS required, advanced degrees such as MS or PhD desirable
-Experience in dermatology and/or ophthalmology is desirable, but not required
-Highly capable team player with strong interpersonal skills
-Leadership initiative
-Ability to multi-task and complete assignments on time

This is an incredible chance to join a reputable pharmaceutical company with a stable team. Don't miss out on the opportunity to be at the forefront of some exciting new work at a company with international presence. Apply today and send resumes to Jess Lakis at Real Pharma; reach me at 212-707-8499.
To find out more about Real please visit www.realstaffing.com