Senior Medical Writer/Principal Medical Writer

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

📋 Description

• Oversee the creation of high-quality clinical study documents within set timelines.

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

• Generate documents adhering to the Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD standards.

• Independently distill key messages from clinical study data.

• Create complex content by leveraging knowledge of relevant processes.

• Engage in communication with internal teams and clients.

• Ensure efficient document management from template creation to final approved version, collaborating closely with sponsors, external vendors, and internal Precision teams/departments.

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

• Conduct literature-based research to enhance writing efforts.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

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

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

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

• Solid understanding of relevant regulations, including ICH, FDA, and GCP.

• Familiarity with clinical trial transparency mandates, such as EudraCT and CT.gov.

• Knowledge of eCTD requirements across all development phases.

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

• Capability to thrive in a fast-paced environment with multiple high-priority assignments, requiring minimal instruction for routine tasks and limited guidance for new assignments.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and training.

• Flexible work arrangements to promote work-life balance.

• Collaborative and supportive work culture.