Senior Medical Writer / Principal Medical Writer

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

📋 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's Brochures (IBs), Informed Consent Form (ICF) templates, Development Safety Update Reports (DSURs), Clinical Study Reports (CSRs), and CSR patient narratives.

• Create documents that adhere to the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), relevant regulatory guidelines, and electronic Common Technical Document (eCTD) requirements.

• Manage documents from template creation to final approved versions in collaboration with sponsors, external vendors, and internal Precision project teams or departments.

• Independently distill key messages from clinical study data.

• Author intricate content utilizing knowledge of pertinent processes.

• Effectively communicate in a clear and concise manner with both internal and client teams.

• Assist in the development and upkeep of medical writing processes, SOPs, templates, and work instructions.

• Conduct literature-based research to support writing endeavors.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

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

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

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

• Thorough understanding of applicable regulations, including ICH, FDA, and GCP.

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

• Knowledge of eCTD requirements across all phases of development.

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

• Capability to work efficiently in a dynamic environment with multiple high-priority projects, requiring minimal instruction.

• Advanced degree (MS/PhD) is preferred.

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

🏝️ Benefits

• Comprehensive health insurance options.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and training.

• Flexible work environment and potential for remote work.

• Employee wellness programs and initiatives.