Senior Medical Writer/Principal Medical Writer (Clinical)

Location: Remote, Serbia

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 QC review of clinical study documents, including protocols, investigator brochures, informed consent templates, DSURs, CSRs, and patient narratives.
• Manage documents from templates through final approval in collaboration with sponsors, vendors, and internal project teams.
• Formulate key messages from clinical study data and author complex regulatory content.
• Apply ICH, FDA, GCP, clinical trial transparency, and eCTD requirements across development phases.
• Contribute to medical writing processes, SOPs, templates, and work instructions.
• Perform 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.
• 5+ years of experience as a Senior Medical Writer in a sponsor or CRO setting, or 7+ years as a Principal Medical Writer.
• Experience with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Clear understanding of ICH, FDA, GCP, clinical trial transparency requirements, EudraCT, ClinicalTrials.gov, and eCTD requirements.
• Strong attention to detail and ability to manage multiple high-priority assignments independently in a fast-paced environment.
• Must be legally authorized to work in Serbia 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 from Serbia.
• Collaboration with sponsors, external vendors, and internal cross-functional teams.
• Work across multiple clinical development projects and document types.