Senior Medical Writer

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

📋 Description

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

• Engage in clinical document planning, writing, editing/formatting, and conducting QC reviews.

• Produce documents that adhere to the Precision MW Style Guide, Precision SOPs, and relevant regulatory guidelines (e.g., ICH, FDA, GCP) as well as eCTD requirements.

• Ensure efficient document management throughout the entire process, from template creation to the final approved version.

• Demonstrate the ability to independently extract key messages from clinical study data.

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

• Conduct literature-based research to support writing tasks.

⛳️ 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 medical writer in either a sponsor or CRO environment.

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

• Comprehensive understanding of applicable regulations (such as ICH, FDA, GCP), clinical trial transparency requirements (i.e., EudraCT, CT.gov), and eCTD requirements for all development phases.

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

• Ability to function effectively in a fast-paced setting, managing multiple high-priority projects with minimal guidance on routine tasks and limited instruction on new assignments.

🏝️ Benefits

• Health insurance

• Retirement savings benefits

• Life insurance

• Disability benefits

• Parental leave

• Paid time off for sick leave and vacation