Senior Medical Writer (Medicine)

TL;DR

Senior Medical Writer (Medicine): Leading the development of high-quality clinical study documents with an accent on regulatory compliance and document planning. Focus on authoring protocols, IBs, and CSRs while ensuring strict adherence to ICH, FDA, and GCP guidelines.

Location: Remote (United States)

Salary: $100,600 - $151,000 USD

Company

hirify.global is a service provider specializing in clinical research and high-quality medical writing for sponsors and CROs.

What you will do

• Lead the planning, writing, editing, and QC review of clinical study protocols, IBs, ICF templates, DSURs, and CSRs.
• Manage the end-to-end document lifecycle from template creation to final approved version in collaboration with sponsors and internal teams.
• Formulate key messages from clinical study data and author complex technical content.
• Contribute to the development and maintenance of medical writing SOPs, templates, and work instructions.
• Perform literature-based research to support clinical writing activities.
• Ensure all documents comply with Precision MW Style Guide and applicable regulatory guidelines (ICH, FDA, GCP).

Requirements

• BS degree in a scientific or medical discipline.
• Minimum 5+ years of experience as a medical writer in a sponsor and/or CRO setting.
• Must be based in the United States.
• Deep understanding of ICH, FDA, GCP regulations, eCTD requirements, and clinical trial transparency (EudraCT, CT.gov).
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams) and Adobe Acrobat.

Nice to have

• Advanced degree (MS/PhD).
• Experience in Oncology and/or rare disease (specifically protocol and CSR development).

Culture & Benefits

• Discretionary annual bonus.
• Comprehensive health, life, and disability insurance.
• Retirement savings benefits.
• Paid time off for vacation and sick leave.
• Parental leave.