Senior Medical Writer (Protocols)

MMS seeks a Senior Medical Writer (Protocols) to join our team in the United States. As a full-time member of our regulatory and clinical operations group, you'll author clinical trial protocols and supporting documentation for pharmaceutical, biotech, and medical device sponsors worldwide.

About the Role

This Senior Medical Writer (Protocols) position is central to MMS's mission of delivering high-quality regulatory and clinical solutions to life sciences companies. You'll develop comprehensive clinical trial protocols, protocol amendments, and related technical documents that guide complex studies from design through completion. Your work directly impacts regulatory submissions and trial execution for sponsors navigating the most demanding therapeutic areas and regulatory environments.

Day-to-Day Responsibilities

• Author and revise clinical trial protocols, statistical analysis plans, and case report forms
• Incorporate sponsor requirements, regulatory guidance, and emerging trial design best practices into protocol documentation
• Partner with clinical programmers, project managers, and regulatory specialists to ensure accuracy and compliance
• Review protocol-related deliverables for consistency, clarity, and adherence to regulatory and ICH-GCP standards
• Communicate protocol findings and recommendations to internal teams and client stakeholders
• Manage multiple protocol projects simultaneously, meeting strict timelines in a deadline-driven environment

Who We're Looking For

• 5+ years of medical writing experience, with substantial focus on clinical trial protocol development
• Deep familiarity with ICH-GCP, FDA guidance documents, and international regulatory requirements
• Advanced expertise in study design terminology, statistical concepts, and clinical trial operations
• Excellent written and verbal communication skills with attention to precision and detail
• Demonstrated ability to manage complex, multi-stakeholder projects in a collaborative environment
• Bachelor's degree in life sciences, healthcare, or related field (advanced degree preferred)

Working at MMS

MMS is a data-driven CRO that has built a reputation for scientific rigor and customer success. Our global team spans four continents, and we maintain a 97 percent customer satisfaction rating by combining expert talent with innovative approaches to trial data and regulatory challenges. You'll work alongside experienced colleagues who share a commitment to high-quality deliverables and client partnership.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.