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Bio-Med Medical Writer

Location: Chicago Region
Category: Healthcare
Employment Type: Contract To Hire

Medical Writer

Primary Responsibilities:

  • Writes clinical protocols, clinical study reports, investigator's brochures and other clinical documents in conjunction with the project team.
  • Manages and reviews the writing of Clinical Evaluation Reports (CERs)
  • Writes, reviews, and/or edits publications (manuscripts, abstracts, poster presentations, etc.)
  • Drives document writing and review processes
  • Develops and maintains timelines for document generation, revision, and completion, in collaboration with other study team members
  • Responsible for tracking, initiating, coordinating, and managing routine review cycles for various document types. Incorporates team comments, and leads discussions on document revision and finalization.
  • Assists in the development and maintenance of SOPs and writing tools, such as templates and style manuals
  • Provides standardization and training on use of medical writing templates, SOPs, and processes within the department and across departments
  • Contributes to the development of electronic document systems and tools
  • Provides quality control (QC) review of various regulatory and medical communications documents
  • Provides project team(s) with guidance and problem resolution related to document generation
  • Takes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
  • Acts as an authoritative resource within specialty area to internal and external resources
  • Works effectively with colleagues from other departments in team situations


  • Extremely detail oriented 
  • Exceptional organizational skills 
  • Exceptional writing skills 
  • Exceptional proofreading skills 
  • Must be highly proficient in Microsoft office products 
  • Able to set and maintain both short and long term deadlines 
  • Able to troubleshoot difficult or sensitive problems and find positive solutions 


  • Bachelor’s degree in science, health profession, or journalism. 
  • Minimum of 2-3 years’ experience writing for Bio-Med
  • Advanced degree in science, health profession, or journalism is preferred. 
  • Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission. 
  • Able to understand FDA/international regulations, ICH guidelines, and applicable U.S./international regulatory processes related to document preparation and production (including CTDs). 
  • Able to understand guidelines and requirements related to the preparation and production of regulatory documents and submissions. 
  • Demonstrate problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external providers.