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, compose, 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.

• Generate documents adhering to the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), relevant regulatory directives, and electronic Common Technical Document (eCTD) requirements.

• Facilitate efficient document management from template stage to final approved version, collaborating with sponsors, external vendors, and internal teams/departments at Precision.

• Independently craft essential messages derived from clinical study data.

• Compose intricate content utilizing expertise, skills, and a comprehensive understanding of processes.

• Convey information clearly and succinctly in both written and verbal formats to 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.

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

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

• Solid understanding of relevant regulations, including ICH, FDA, and Good Clinical Practice (GCP).

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

• Knowledge of eCTD requirements across all development phases.

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

• Capable of thriving in a fast-paced setting with numerous high-priority projects, requiring minimal guidance on routine tasks and limited instruction for new assignments.

🏝️ Benefits

• Competitive salary and compensation package.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness benefits.

• Flexible working arrangements.