job summary: Seeking an experienced senior level Medical Writer. The ideal candidate should have 3+ years of regulatory writing experience. location: Northbrook, Illinois job type: Permanent salary: $150,000 - 165,000 per year work hours: 9 to 5 education: Bachelors responsibilities: May include but not limited to the following: Under minimal supervision, writes and edits clinical study reports, protocols, informed consent forms, and other clinical and regulatory documents including Investigator Brochures and annual reports.Assists with the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs) as needed.Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).Reviews case report forms, statistical analysis plans, and data tables and listings for content and format.Participates in clinical project team meetings.Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards. qualifications: ? Education: Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience. Experience: 3+ years experience writing/editing clinical regulatory documents including clinical study reportsPharmaceutical industry experience and background in biologics a plus Special Skills: Excellent writing, editing, attention to detail and verbal communication skillsAbility to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areasProficiency in Microsoft WordFamiliarity with CTD, ICH, GCP and other standardsAbility to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment skills: GCP (Good Clinical Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.