Lead Medical Writer — Regulatory & Publications

Alimentiv; Ottawa; On-site; CAD 90,000 - 130,000; Full time

Job summary

Alimentiv seeks a skilled Medical Writer to provide writing and consultation to Clinical Research Scientists, Academic partners, Sponsors, and the corporation. You will research, write, edit regulatory documents, translate data into protocols, ICFs, CSRs, and study briefs, and present information in a timely manner and in line with industry standards.

You will lead content planning for protocols, ICFs, and CSRs, coordinate reviews with authors, manage writing deliverables, and support

Qualifications

• Minimum undergraduate degree; advanced degrees preferred.
• 3–5 years of relevant medical writing experience.
• Experience leading 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.
• Ability to adapt to shifting priorities.
• Highly refined written and oral communication skills.
• Diplomacy and tact when working with teams.
• Experience/knowledge of Gastroenterology is an asset.
• Familiarity with ICH M11 and AMA Style Guide is an asset.
• Open to embracing new technologies.

Responsibilities

• Lead the content planning and production of regulatory documents (protocols, ICFs, CSRs) in alignment with standards.
• Coordinate completion of specialized content with authors to translate, write, edit and proof data for publication.
• Act as project manager for writing deliverables and track timelines.
• Participate in quality control reviews of documents written by others.]
• Act as primary liaison with external publication executives, illustrators, designers, and editors.
• Support study teams with review, editing or proofreading of study documents or templates.
• Assist with writing or reviewing training materials or work instructions when requested.

Skills

Written and oral communication

Diplomacy and tact

GCP/GDPR/HIPAA training

EndNote / reference software

Graphical software/figure development

Adapt to shifting priorities

Gastroenterology knowledge asset

Education

Undergraduate degree

Advanced degree preferred

Tools

EndNote

Graphic/figure software

Job description

Alimentiv seeks a skilled Medical Writer to provide writing and consultation to Clinical Research Scientists, Academic partners, Sponsors, and the corporation. You will research, write, edit regulatory documents, translate data into protocols, ICFs, CSRs, and study briefs, and present information in a timely manner and in line with industry standards.

You will lead content planning for protocols, ICFs, and CSRs, coordinate reviews with authors, manage writing deliverables, and support