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, draft, edit, format, and conduct quality control reviews for 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 accordance with the Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD requirements.

• Manage the document lifecycle from template creation to the final approved version, collaborating with sponsors, external vendors, and internal Precision project teams and departments.

• Independently formulate key messages derived from clinical study data.

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

• Communicate effectively and succinctly with both internal and client teams.

• Assist in the development and maintenance of medical writing processes, standard operating procedures (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 proficiency.

• 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.

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

• Exceptional attention to detail and capability to complete writing tasks punctually.

• Ability to thrive in a fast-paced setting with several high-priority projects, working independently on routine tasks and requiring minimal guidance on new assignments.