Medical Writer, QC Specialist

Medical Writer, QC Specialist

About Artos

Artos is revolutionizing regulatory document creation with AI. We work with leading life sciences companies to streamline medical writing and submission processes, ensuring accuracy, efficiency, and compliance. As we scale, we are continuously improving our AI-driven systems, producing high-quality regulatory documents at scale.

The Role

We are looking for a Medical Writer with a Quality Control (QC) specialization to help ensure the accuracy, clarity, and compliance of the documents produced by our AI-powered platform. Quality is what makes us unique, and this role is critical in ensuring our outputs meet the highest standards expected in regulatory submissions.

In this role, you will:

• Review and QC regulatory documents (e.g., clinical study reports, investigator brochures, protocols, IND/CTA/NDA/BLA submissions) generated by our AI platform during product development.
• Ensure accuracy, clarity, and compliance with regulatory guidelines (ICH, FDA, EMA) and internal style guides.
• Identify and report quality issues, inconsistencies, and errors within AI-generated text and structured content to engineering team.
• Provide feedback to improve our AI systems, refining outputs based on linguistic, scientific, and regulatory requirements.
• Develop and refine QC processes and checklists to enhance document quality and consistency.
• Collaborate closely with our AI engineers and medical writing teams to continuously improve document quality and system outputs.

Who You Are

• Experience: 5+ years in medical writing, preferably with a focus on regulatory submissions and quality control.
• Attention to Detail: You have an exceptional ability to spot errors, inconsistencies, and deviations from regulatory requirements.
• Regulatory Expertise: Familiarity with FDA, EMA, and ICH guidelines, and experience reviewing documents for compliance.
• Process-Oriented: You can create, refine, and enforce QC workflows to ensure high-quality document outputs.
• Tech-Savvy: Experience working with document automation, AI-powered writing tools, or structured content management is a plus.
• Collaborative: You thrive in a fast-paced startup environment, working cross-functionally with engineers, medical writers, and regulatory teams.

Why Join Artos?

• Be part of a quickly growing YC-backed startup at the forefront of AI.
• Work on complex problems for some of the largest organizations in the life sciences.
• Have a direct impact on ensuring document quality and regulatory compliance at scale.
• Collaborate with a team of experts in medical writing, AI, and regulatory affairs.

🔹 Interested? Apply now to help us shape the future of medical writing and regulatory submissions.