Seeking an experienced senior level Medical Writer. The ideal candidate should have 3+ years of regulatory writing experience.
location: Northbrook, Illinois
job type: Outsourcing Project
salary: $70 - 80 per hour
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.
- 3+ years experience writing/editing clinical regulatory documents including clinical study reports
- Pharmaceutical industry experience and background in biologics a plus
- Excellent writing, editing, attention to detail and verbal communication skills
- Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas
- Proficiency in Microsoft Word
- Familiarity with CTD, ICH, GCP and other standards
- Ability 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.
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