Senior Medical Writer/Principal Medical Writer

Location: Remote, Hungary

Company

hirify.global provides clinical development and medical writing services for pharmaceutical and life sciences programs.

What you will do

• Plan, write, edit, format, and perform QC reviews of clinical study protocols, investigator brochures, informed consent templates, DSURs, CSRs, and CSR patient narratives.
• Develop documents in compliance with Precision style guides, SOPs, ICH, FDA, GCP, and eCTD requirements.
• Manage documents from initial templates through final approved versions in collaboration with sponsors, vendors, and internal project teams.
• Formulate key messages from clinical study data and author complex clinical content independently.
• Contribute to medical writing processes, SOPs, templates, and work instructions.
• Conduct literature-based research and communicate clearly with internal and client teams.

Requirements

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
• At least 5 years of experience as a Senior Medical Writer in a sponsor or CRO setting, or at least 7 years as a Principal Medical Writer.
• Understanding of ICH, FDA, GCP, clinical trial transparency requirements, EudraCT, ClinicalTrials.gov, and eCTD requirements across development phases.
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Strong attention to detail and ability to manage multiple high-priority projects with minimal instruction.
• Must be legally authorized to work in Hungary without employer sponsorship.

Nice to have

• Advanced degree such as an MS or PhD.
• Oncology or rare disease experience, especially protocol and CSR development.

Culture & Benefits

• Remote work arrangement in Hungary.
• Collaboration with sponsors, external vendors, and multidisciplinary internal teams.
• Work across multiple high-priority clinical development projects.