Senior Associate, Quality Control
AbbVie
August 20, 2026
Remote friendly (Chicago, IL)
United States
$84,500 - $162,000 USD yearly
Operations
Purpose:
The Strategic Medical Writing Operations Team delivers high-quality, scientifically accurate, strategically aligned clinical and regulatory documentation supporting AbbVie’s mission.
Responsibilities:
- Define scope of quality control activities with the document author, source documents, and required data; perform independent quality control review per applicable checklist by comparing to source documents.
- Ensure quality control documentation is complete/accurate and uploaded to the master file per established business processes.
- Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes.
- Mentor and train less-senior medical writing operations staff; provide oversight/supervision of 2+ contractors as delegated.
- Lead development, implementation, and maintenance of medical writing operations business processes; act as SME for the master file system and quality control.
- Manage quality control outsourced to vendors, including training and preparation of required QC documentation (e.g., clinical documents, checklists).
- Communicate QC deliverables to stakeholders; demonstrate interpersonal, organizational communication, and conflict management skills.
Qualifications:
- Bachelor’s degree required; Science, English, or Communication preferred.
- 3–4 years relevant industry experience in QC/review of clinical regulatory documents or related (quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D). Higher education may substitute.
- Project management experience preferred.
- Excellent knowledge of clinical documents, eCTD structure, and CTD content templates.
- Working knowledge of global regulatory requirements and guidance for scientific publications and clinical regulatory submissions; strong business-process application.
- Ability to prioritize under changing/urgent workloads; analytical/critical thinking.
- Strong communication, interpersonal/organizational, conflict management, and attention to detail; ability to prioritize multiple tasks/projects.
- Experience with collaborative cross-functional teams.
- Computer/technical skills for process improvements/automation.
- Proficient with Microsoft Office (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe; experience with DocX or similar tools and eTMF/eSubmissions systems (Veeva Vault, CARA).
The Strategic Medical Writing Operations Team delivers high-quality, scientifically accurate, strategically aligned clinical and regulatory documentation supporting AbbVie’s mission.
Responsibilities:
- Define scope of quality control activities with the document author, source documents, and required data; perform independent quality control review per applicable checklist by comparing to source documents.
- Ensure quality control documentation is complete/accurate and uploaded to the master file per established business processes.
- Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes.
- Mentor and train less-senior medical writing operations staff; provide oversight/supervision of 2+ contractors as delegated.
- Lead development, implementation, and maintenance of medical writing operations business processes; act as SME for the master file system and quality control.
- Manage quality control outsourced to vendors, including training and preparation of required QC documentation (e.g., clinical documents, checklists).
- Communicate QC deliverables to stakeholders; demonstrate interpersonal, organizational communication, and conflict management skills.
Qualifications:
- Bachelor’s degree required; Science, English, or Communication preferred.
- 3–4 years relevant industry experience in QC/review of clinical regulatory documents or related (quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D). Higher education may substitute.
- Project management experience preferred.
- Excellent knowledge of clinical documents, eCTD structure, and CTD content templates.
- Working knowledge of global regulatory requirements and guidance for scientific publications and clinical regulatory submissions; strong business-process application.
- Ability to prioritize under changing/urgent workloads; analytical/critical thinking.
- Strong communication, interpersonal/organizational, conflict management, and attention to detail; ability to prioritize multiple tasks/projects.
- Experience with collaborative cross-functional teams.
- Computer/technical skills for process improvements/automation.
- Proficient with Microsoft Office (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe; experience with DocX or similar tools and eTMF/eSubmissions systems (Veeva Vault, CARA).