Senior Medical Writer
Location
Canada
Posted
59 days ago
Salary
$101.8K - $152.6K / year
Seniority
Senior
Job Description
Senior Medical Writer
Precision For Medicine
• leading the development of high-quality and on-time clinical study documents • clinical document planning, writing, editing/formatting, and performing QC review • develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements • ensures smooth and effective document management from start to finish (ie, from template to final, approved version) • ability to independently formulate key messages from clinical study data • contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents • performing literature-based research to support writing activities
Job Requirements
- BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
- 5+ years of experience as a medical writer in the sponsor and/or CRO setting
- Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint
- Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for all phases of development
- Impeccable attention to detail and ability to complete writing assignments in a timely manner
- Ability to work effectively in a fast-paced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments
Benefits
- health insurance
- retirement savings benefits
- life insurance
- disability benefits
- parental leave
- paid time off for sick leave and vacation
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Certification Specialist
MaximusWe're setting a new standard in men's health. Personalized protocols, prescribed by doctors, proven by blood tests.
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Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Minimum Salary $ 80,000.00 Maximum Salary $ 110,000.00
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