Senior Medical Writer, Principal Medical Writer

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

📋 Description

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

• Plan, compose, edit, format, and conduct QC 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.

• Generate documents in adherence to the Precision MW Style Guide, Precision Standard Operating Procedures (SOPs), relevant regulatory guidelines (ICH, FDA, GCP), and electronic Common Technical Document (eCTD) requirements.

• Manage documents from the initial template stage 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.

• Author intricate content utilizing knowledge, skills, and understanding of processes.

• Communicate effectively and succinctly in both written and verbal formats with internal teams and clients.

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

• Conduct literature-based research to support writing initiatives.

• Perform additional duties 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 CRO environment, or at least 7 years as a Principal Medical Writer.

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

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

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

• Proven ability to thrive in a fast-paced environment managing multiple high-priority projects, with minimal supervision on routine tasks and limited guidance on new assignments.

• An advanced degree (MS/PhD) is preferred.

• Experience in oncology and/or rare diseases, particularly in protocol and CSR development, is preferred.

• Candidates must have legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and training.

• Flexible work arrangements and a positive work-life balance.

• Collaborative and inclusive work environment.