Senior Medical Writer/Principal Medical Writer

Location: Remote, Spain

Company

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

What you will do

• Plan, write, edit, format, and perform quality control review of clinical study documents.
• Develop protocols, investigator brochures, informed consent templates, DSURs, CSRs, and CSR patient narratives.
• Manage documents from template creation through final approval in collaboration with sponsors, vendors, and internal project teams.
• Formulate key messages from clinical study data and author complex regulatory content.
• Conduct literature-based research to support medical writing activities.
• Contribute to medical writing processes, SOPs, templates, and work instructions.

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.
• Strong understanding of ICH, FDA, GCP, clinical trial transparency requirements, and eCTD requirements across all development phases.
• Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Excellent attention to detail, problem-solving ability, and capacity to manage multiple high-priority projects with minimal instruction.
• Must be legally authorized to work in Spain without employer sponsorship.

Nice to have

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

Culture & Benefits

• Remote work arrangement in Spain.
• Collaboration with sponsors, external vendors, and cross-functional internal teams.
• Work across multiple clinical development projects in a fast-paced environment.