Senior Medical Writer/Principal Medical Writer

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

📋 Description

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

• Plan, draft, edit, format, and conduct quality control reviews of clinical documents, including clinical study protocols, investigator brochures (IBs), informed consent form (ICF) templates, development safety update reports (DSURs), clinical study reports (CSRs), and CSR patient narratives.

• Develop documents adhering to the Precision MW Style Guide, Precision standard operating procedures (SOPs), ICH guidelines, FDA regulations, GCP standards, and eCTD specifications.

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

• Independently craft key messages derived from clinical study data.

• Author intricate content utilizing knowledge of pertinent processes.

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

• Contribute to the medical writing processes, standard operating procedures, templates, and work instructions.

• Conduct literature-based research to support writing tasks.

• Perform additional duties as assigned.

⛳️ Requirements

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

• Over 5 years of experience as a Senior Medical Writer in a sponsor and/or CRO environment, or more than 7 years as a Principal Medical Writer.

• Proficient 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 for all stages of development.

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

• Capability to work efficiently in a fast-paced environment with multiple high-priority projects.

• Advanced degree (MS/PhD) is preferred.

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

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Supportive and collaborative team environment.