Offer summary

Qualifications:

Bachelor’s degree or higher in a life science discipline., 3–5 years of experience in regulatory or clinical medical writing, with at least 2 years in QC or document review roles., Experience using or deploying AI/NLP tools in document review or QC settings., Proficiency in Microsoft Word and Excel, and familiarity with regulatory standards..

Key responsibilities:

Conduct QC reviews of clinical and regulatory documents using manual and AI-assisted methods.

Validate data accuracy and consistency against source documents.

Use AI tools to identify inconsistencies in grammar, formatting, and style adherence.

Collaborate with medical writers and participate in process improvements for QC workflows.

Job description

Job Title:
AI-Powered Quality Control Specialist – Regulatory Medical Writing
Position Summary:
We are seeking a detail-oriented and tech-savvy Quality Control (QC) Specialist to join our Regulatory Medical Writing team. This role combines traditional QC expertise with the innovative application of artificial intelligence to ensure the accuracy, consistency, and compliance of regulatory documents. The ideal candidate will have a background in clinical or regulatory writing and experience using or supporting AI tools to optimize content review workflows.
Key Responsibilities:

Conduct QC reviews of moderately to highly complex clinical and regulatory documents (e.g., Clinical Evaluation Reports [CER], Clinical Evaluation Plans [CEP], Clinical Study Reports, Protocols, Investigator's Brochure, Module 2 summaries) using both manual and AI-assisted methods
Validate the accuracy of data, interpretation, and references by comparing against source documents (e.g., statistical outputs, protocols, SAPs)
Use AI tools to flag inconsistencies in grammar, formatting, data presentation, and adherence to style guides
Ensure compliance with internal templates, regulatory guidelines (ICH, FDA), and company SOPs
Collaborate with Medical Writers to improve document clarity, accuracy, and readiness for submission
Provide guidance and troubleshooting on AI-supported QC platforms and workflows
Maintain QC documentation within electronic document management systems (e.g., SharePoint)
Participate in process improvement initiatives, including the development of AI workflows for QC activities

Qualifications:

Bachelor’s degree or higher in a life science discipline
3–5 years of experience in regulatory or clinical medical writing, with at least 2 years in QC or document review roles
Familiarity with clinical development processes and regulatory documentation standards
Experience using or deploying AI/NLP tools in a document review or QC setting (e.g., tools that extract, compare, or validate data/text)
Advanced proficiency in Microsoft Word and Excel, including template management and formatting controls
Familiarity with citation managers (e.g., EndNote) and regulatory document standards (e.g., AMA Style, GCP)
Detail-oriented with excellent organizational and communication skills
Ability to independently manage multiple QC assignments under tight timelines

Preferred Skills:

Familiarity with AI-driven platforms for document processing, such as natural language processing tools or automated QC systems, like PerfectIt, Grammarly, etc.
Experience training others on new digital tools or AI systems

Required profile