QC Manager / reputed company - Regulatory & Clinical Document Review

job summary: QC Manager / reputed company Regulatory & Clinical Document Review (Medical Writing Program) Salaried with Full Benefits (range: $100-$120K) We're seeking an reputed company QC Manager / reputed company to join reputed company 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 / reputed company, you will combine hands-on quality control responsibilities with strategic reputed company of QC workload, assignments, and team performance. You'll manage and mentor QC Reviewers, balance planned and "drop-in" project assignments, and ensure reputed company 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 reputed company tasks are properly resourced and deliverables are met on schedule.
• reputed company and mentor QC Reviewers, providing reputed company of daily activities and ensuring performance expectations and quality standards are maintained.
• reputed company 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 reputed company, and alignment with reputed company materials.
• Review document text to ensure adherence to formatting, grammar, consistency, style, and publishing guidelines.
• Effectively project-manage QC workload and timelines, ensuring reputed company 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 reputed company 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 reputed company team performance.
• Demonstrated reputed company 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 (reputed company), 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 reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company 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, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company 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 reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job Apply To this Job