Medical Writer

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

📋 Description

• Deliver medical writing services and consultancy to Clinical Research Scientists, academic collaborators, sponsors, and/or the corporation.

• Investigate, compose, review, and refine scientific documentation.

• Organize document reviews in collaboration with authors.

• Execute reference searches and validate citations.

• Convert research data and findings into regulatory documents and presentations, such as protocols, investigator brochures, clinical study reports, and informed consent forms.

• Monitor progress and deadlines for assigned writing tasks.

• Conduct quality control reviews of documents upon request.

• Oversee content planning and the creation of regulatory documents.

• Coordinate specialized content with authors and technical experts.

• Translate, write, edit, and proofread data and content for finalized documents.

• Function as project manager for writing deliverables, track timelines, and provide status reports.

• Engage in quality control review of documents authored by others.

• Collaborate with external publication executives, illustrators, designers, and editors.

• Assist study teams with the review, editing, or proofreading of study documents and templates.

• Help develop or review training materials and work instructions.

⛳️ Requirements

• A minimum of an undergraduate degree (advanced degrees preferred).

• 3-5 years of relevant experience in medical writing.

• Prior experience in leading the development of protocols, informed consent forms (ICFs), and clinical study reports (CSRs).

• Trained in Good Clinical Practice (GCP), General Data Protection Regulation (GDPR), and Health Insurance Portability and Accountability Act (HIPAA).

• Advanced proficiency in EndNote/reference software.

• Familiarity with graphical software and figure development is advantageous.

• Ability to adapt to changing priorities and assignments.

• Exceptional written and verbal communication skills.

• Proven ability to work with diplomacy and tact.

• Previous experience or knowledge in Gastroenterology is beneficial.

• Familiarity with ICH M11 and the AMA Style Guide is a plus.

• A mindset focused on continuous improvement and a willingness to adopt new technologies when appropriate.

🏝️ Benefits

• Bonus.

• Full-time, permanent employment.