Back to Results
Bio-Med Medical Writer
Location: Chicago Region
Employment Type: Contract To Hire
- 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.