Job Listing: Director, Medical Writer

"Large and growing Pharmaceutical Company located in Princeton, NJ seeks for a Director of Medical Writing"

Duties and Responsibilities:

-Directs the medical writing department/staff in the writing/rewriting, editing and preparation of manuscripts on clinical studies and scientific reports including special summaries from raw data for submission to the FDA or for in-company use, monographs, comprehensive reviews, scientific exhibits.
-Manages the Central Product Information processes in reference to safety information including, but not limited to: the development/review of SPC’s, CDS’, PI’s, PSUR’s, EU ASR’s and the coherence between product labeling and CDS’s and adjunct safety information.
-Manages vendor selection process for Phase I-IV WW clinical studies for any regulatory clinical document.
-Develops and manages the RA budget with support and input from RA Senior Management.
-Directs preparation and implementation of global policies, standard operating procedures, processes and standards.
-Manages resource allocation and assures appropriate resources are available to meet objectives.
-Develops and maintains lines of communication across Global MW, Drug Safety and Regulatory Affairs.

Core Competencies:

-Demonstrated medical writing skills and a high level of interpersonal skills to interact effectively in team and matrix work settings. Sensitivity to cultural differences.
-Extensive knowledge of worldwide registration document requirements including ICH guidelines, EMEA requirements and FDA guidelines and requirements.
-Demonstrated written/oral communication skills combined with supervisory and management skills. Able to manage and motivate a highly skilled professional staff.

Education and/or Experience Required:

-B.A/B.S. degree, advanced degree preferred.
-7-10 years experience in regulatory writing or equivalent within the pharmaceutical industry, including supervising and managing a medical writing group.
-Experience with medical imaging agents preferred.
-Experience in filing applications for marketing authorizations in Europe and other ex-U.S. regions. Experience in Japan and China helpful.
-Experience working with an electronic- based document management system.



- International travel, generally to European Countries required.

Required Skills for Director, Medical Writer Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.