Medical Writer

In this role you will be providing medical writing services and consultation to Clinical Research Scientists, Academic partners, Sponsors and/or the Corporation, which may include researching, writing, reviewing and editing scientific information, coordinating document reviews with authors, conducting reference searches and verifying citations, translating research data and findings into  regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms, etc.) and presentations on a timely basis and in alignment with industry, regulatory and academic style and content guidelines and standards. Track progress and timelines for assigned writing projects. Perform document quality control review when requested. Assist with writing or review of relevant training materials or work instructions as needed.

• Minimum of an undergraduate degree (advanced degrees preferred) and 3-5 years of relevant experience in medical writing.
• Previous experience leading the development of protocols, ICFs, and CSRs
• Trained in GCP, GDPR, and HIPAA
• Advanced knowledge of EndNote/reference software
• Familiarity with graphical software and figure development is an asset.
• Ability to adapt to shifting priorities and assignments.
• Highly refined written and oral communication skills.
• Demonstrated ability to work with diplomacy and tact.
• Previous experience/knowledge of Gastroenterology is an asset.
• Familiarity with ICH M11 and the AMA Style Guide is an asset.
• Continuous improvement mindset and willingness to embrace new technologies where appropriate