Senior Medical Writer/Principal Medical Writer

Location: Remote, Romania. Candidates must be legally authorized to work in Romania without employer sponsorship.

Company

hirify.global employs medical writing professionals to support clinical development documentation and regulatory submissions.

What you will do

• Plan, write, edit, format, and perform QC reviews for clinical study protocols, investigator brochures, informed consent templates, DSURs, CSRs, and CSR patient narratives.
• Manage documents from template development through final approval in collaboration with sponsors, external vendors, and internal project teams.
• Formulate key messages from clinical study data and author complex clinical content independently.
• Ensure compliance with Precision style guides, SOPs, ICH, FDA, GCP, clinical trial transparency, and eCTD requirements.
• Conduct literature-based research and contribute to medical writing processes, SOPs, templates, and work instructions.
• Communicate clearly with internal and client teams while managing multiple high-priority projects.

Requirements

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise.
• 5+ years of experience as a Senior Medical Writer in a sponsor or CRO setting, or 7+ years as a Principal Medical Writer.
• Clear understanding of ICH, FDA, GCP, clinical trial transparency requirements, and eCTD requirements across development phases.
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Excellent attention to detail, problem-solving ability, and capacity to complete assignments on time with minimal supervision.
• Legal authorization to work in Romania without employer sponsorship is required.

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 based in Romania.
• Collaboration with sponsors, vendors, and internal clinical project teams.
• Work across multiple clinical development projects and document types.