QC Manager / Lead - Regulatory & Clinical Document Review

job summary: QC Manager / Lead Regulatory & Clinical Document Review (Medical Writing Program) Salaried with Full Benefits (range: $100-$120K) We're seeking an experienced QC Manager / Lead to join Randstad Life Sciences' internal Medical Writing Program, supporting a leading global pharmaceutical partner. This position offers a unique opportunity to contribute to a high-performing, long-term program dedicated to a single client partnership. As the QC Manager / Lead, you will combine hands-on quality control responsibilities with strategic oversight of QC workload, assignments, and team performance. You'll manage and mentor QC Reviewers, balance planned and "drop-in" project assignments, and ensure all regulatory and clinical documentation meets established accuracy, consistency, and compliance standards. location: Northbrook, Illinois job type: Outsourcing Project salary: $50 - 55 per hour work hours: 9 to 5 education: Bachelors responsibilities:

• Manage QC workload and assignments, ensuring all tasks are properly resourced and deliverables are met on schedule.
• Lead and mentor QC Reviewers, providing oversight of daily activities and ensuring performance expectations and quality standards are maintained.
• Perform quality control reviews of global regulatory documents and submissions including clinical study synopses, investigator brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs), and Common Technical Documents (CTDs)to verify content accuracy, data integrity, and alignment with source materials.
• Review document text to ensure adherence to formatting, grammar, consistency, style, and publishing guidelines.
• Effectively project-manage QC workload and timelines, ensuring all medical writing deliverables meet client SOPs and quality expectations.
• Conduct electronic QC (eQC) checks per client SOPs, verifying hyperlink functionality and accuracy of literature reference links.
• Participate in management and client meetings as required, providing QC updates and contributing to process improvements.

qualifications:

• Solid understanding of the pharmaceutical drug development process.
• Minimum of 3 years of quality control experience within the medical writing field.
• Strong working knowledge of International Council for Harmonisation (ICH) and Code of Federal Regulations (CFR) guidelines.
• High proficiency with Windows-based applications and relevant medical/scientific publication tools, including CTD submission platforms, DocX, Quosa, and SharePoint.
• Proven ability to manage direct reports and oversee team performance.
• Demonstrated capacity to manage multiple priorities and meet tight deadlines.
• Excellent organizational and time-management skills.
• Minimum of 3 years of project management experience.
• Strong verbal and written communication abilities.
• Experience preparing and interpreting metrics reports.
• Collaborative team player with exceptional interpersonal skills.
• Strong attention to detail and commitment to quality.

#LI-AT1 skills: Editing, QC Review, Clinical Study Report (CSR), Investigator Brochure (IB), Informed Consent Form (ICF), Common Technical Document (CTD), Briefing Documents for Regulatory Agencies, American Medical Writers Association (AMWA), Clinical Study Protocol Summaries 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. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job Apply To this Job