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Principal Medical Writer - Remote

North Chicago, Illinois

Post Date: 07/27/2017 Job ID: 1540 Job Category: Clinical: Medical Writing

Growing global sponsor is seeking Remote Medical Writers who are responsible for providing clinical regulatory document support to their clinical teams, ensuring high quality submission-ready documents.

Job Responsibilities:
  • Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
  • Coordinates the review and approval involved in the production of clinical regulatory projects.
  • Understands, assimilates, and productively interprets sources of information, Ensures required documentation is obtained, including internal and external studies, research documentation, charts, graphs, and tables.
  • Arranges and conducts review meetings with the team.
  • Independently resolves document content issues and questions arising during the writing process.
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.
  • Recommends, leads, and implements tactical process improvements.

  
Qualifications/Requirements:

  • Bachelor of Science required, with significant relevant writing experience, or Bachelor' s degree in English or communications, with significant relevant science experience.
  • High-level content writing experience and experience with all types of clinical regulatory documents required.

Preferred:
  • Masters or PhD in science discipline preferred with relevant writing experience.
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
  • Knowledge and expertise with Common Technical Document content templates.
  • Expert knowledge of current electronic document management systems and information technology.
  • Excellent written and oral communication skills. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.
  • Working knowledge of statistical concepts and techniques.
  • Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
  • Expert in word processing, flow diagrams, and spreadsheets.
  • Excellent working knowledge of software programs in Windows environment.

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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