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Regulatory Medical Writer
Ref No.: 18-00637
Location: Lawrence Township, New Jersey
Position Type:Contract
Start Date: 05/10/2018
REGULATORY MEDICAL WRITER
LAWRENCE TOWNSHIP, NJ


Project Description:
The Medical Writing Contractor, is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects. The "hands-on” Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements in eCTD format.
  • Coordination and preparation of Meeting Content Packages and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, and investigator brochures for Phase I to IV clinical trials.

Required Skills:
  • Competency in the use of Documentum (or a similar document management system) is preferable.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Michelle: michellea@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00637
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE