Seeking a detail oriented Sr. QC reviewer to join our FSP team. The primary role of the Sr. QC Reviewer is to perform scientific quality review of regulatory documents to ensure date integrity and compliance with applicable regulatory requirements. This is a full-time remote position that offers aid holidays, PTO, medical and dental benefits.
location: Northbrook, Illinois
job type: Outsourcing Project
salary: $40 - 45 per hour
work hours: 9 to 5
- Perform quality reviews of global regulatory documents and submissions including: clinical study reports (CSR), CSR appendices, CSR amendments, synopses, patient narratives, statistical analysis plans, investigator brochures, protocols, amendments, Investigational Medicinal Product Dossiers (IMPDs) and Common Technical Documents (CTDs) for content and data accuracy with sources
- Ensure the all documents meet designated requirements for formatting, consistency, grammar, style guidelines and publishing guidelines.
- Bachelor's degree required, Prefer Nursing or Scientific Degree
- Master's Degree preferred in Medical/Scientific field
- Understanding of the pharmaceutical drug development process
- Must have Quality Control experience in the Medical Writing field
- Working knowledge of ICH and CFR regulatory guidelines
- High proficiency with Windows based applications and medical/scientific publication databases/resources
- Ability to manage multiple priorities and meet deadlines
- Excellent organizational and time management skills
- Strong oral and written communication skills
- Team player with excellent interpersonal skills
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.
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.