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Regulatory Medical Writer

Company: Alpha Consulting Corp.
Location: Trenton
Posted on: May 15, 2018

Job Description:

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: ALPHA'S REQUIREMENT #18-00637 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE - provided by Dice (MEDICAL WRITER ) AND (INVESTIGATOR BROCHURES OR CLINICAL TRIAL OR CSR OR CLINICAL STUDY REPORTS OR REGULATORY ) AND(ECTD OR E-CTD )

      Keywords: Alpha Consulting Corp., Trenton, Regulatory Medical Writer, Healthcare, Trenton, New Jersey

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