Senior Medical Writer / Principal Medical Writer

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

📋 Description

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

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

• Create documents in accordance with the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), ICH, FDA, GCP, and eCTD standards.

• Manage documents from initial template through to the final approved version in collaboration with sponsors, external vendors, and internal Precision project teams and departments.

• Independently distill key messages from clinical study data.

• Write complex content utilizing relevant knowledge, skills, and process understanding.

• Communicate effectively and succinctly with both internal teams and clients.

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

• Conduct literature-based research to support writing tasks.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

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

• A minimum of 5 years as a Senior Medical Writer in a sponsor and/or CRO environment, or 7+ years as a Principal Medical Writer.

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

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

• Exceptional attention to detail and capability to complete writing tasks punctually.

• Ability to thrive in a fast-paced environment handling multiple high-priority projects with minimal guidance on routine tasks and limited direction on new assignments.

• Advanced degree (MS/PhD) is preferred.

• Experience in oncology and/or rare diseases is preferred.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and career advancement.

• Collaborative and innovative work environment.