Senior Medical Writer/Principal Medical Writer

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Oversee the creation of high-quality clinical study documents delivered on schedule.

• Organize, draft, edit, format, and conduct quality control reviews of clinical documents such as study protocols, Investigator Brochures (IBs), Informed Consent Form (ICF) templates, Development Safety Update Reports (DSURs), Clinical Study Reports (CSRs), and CSR patient narratives.

• Produce documents in adherence to the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), relevant regulatory guidelines (ICH, FDA, GCP), and electronic Common Technical Document (eCTD) requirements.

• Oversee the documentation process from template to the final approved version, collaborating with sponsors, external vendors, and internal Precision project teams and departments.

• Independently distill essential messages from clinical study data.

• Create complex content leveraging expertise, skills, and process knowledge.

• Clearly and concisely communicate with both internal and client teams.

• Contribute to the development of medical writing processes, SOPs, templates, and operational instructions.

• Conduct literature-based research to support writing tasks.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree or equivalent in a scientific or medical field with pertinent writing experience.

• More than 5 years of experience as a Senior Medical Writer in a sponsor or Contract Research Organization (CRO) environment, or over 7 years as a Principal Medical Writer.

• Strong proficiency in Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.

• Solid understanding of relevant regulations (e.g., ICH, FDA, GCP), clinical trial transparency obligations (EudraCT, CT.gov), and eCTD requirements across all development phases.

• Exceptional attention to detail and the ability to complete writing assignments promptly.

• Capability to thrive in a dynamic environment with numerous high-priority projects, working autonomously on routine tasks and with minimal guidance on new assignments.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Supportive and collaborative work environment.