Requirement SourcePoint | By Innovative

 

  


Requirement Number: 5589

Recruiter Deetria Cannon
Requirement Type Contract
Requirement Category Medical Writer
Location Abbott Park IL
Start Date 05/14/2007
End Date 12/31/2007
Number of Openings 3
Max Pay Rate or Salary $75.00
Job Description Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text, graphs, charts, tables and statistical analysis. Proofreads, circulates, edits, assembles, inspects and duplicates product submissions. 5+ years exp. Requires a Clinical Background. The Medical Writer will be responsible for providing regulatory document support to the clinical teams, ensuring successful preparation of high quality submission-ready documents, and effective implementation of the clinical writing process. Provides expertise in medical writing for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (eg, PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions. May serve as an expert for the department for one or more regulatory document types or compounds. Recommends, leads, and implements process improvements. The qualified candidate must have 4 - 5 years relevant industry experience in medical writing or in a related area such as quality, regulatory, clinical research, or product support/R&D. Two to 4 years as a medical writer in the health care industry required. Two to 4 years experience in experimental design and clinical/preclinical data interpretation preferred. Strong knowledge of US and international regulations, requirements and guidance associated with document preparation and submissions. Knowledge and experience with CTD content templates. Working knowledge of current electronic document management systems and information technology. Excellent written and oral communication skills. Ability to assimilate and interpret scientific content and translate information for appropriate audience. Extensive experience in working with collaborative, cross-functional teams, including process management experience. Superior attention to detail. Computer fluency in word processing, flow diagrams, spreadsheets, and project management software.
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