Lead Medical Writer — Regulatory Documents & Publications

Alimentiv; Toronto; On-site; CAD 69,000 - 116,000; Full time

Job summary

Alimentiv is seeking a Medical Writer to provide medical writing services and regulatory documentation support for Clinical Research Scientists, academics, sponsors, and internal teams. The role includes researching, writing, reviewing, and editing protocols, CSRs, ICFs, and reports, plus coordinating reviews and ensuring timely delivery.

You will manage writing deliverables, track timelines, perform quality control, and assist with training materials as needed, while applying GCP, GDPR, and

Qualifications

• Undergraduate degree required; advanced degrees preferred and 3–5 years of 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 is an asset.
• Strong written and verbal communication; ability to manage shifting priorities.

Responsibilities

• Lead content planning and production of regulatory documents (protocols, ICFs, CSRs) in line with standards.
• Coordinate with authors/experts to translate, write, edit and proof data for publication.
• Act as project manager for writing deliverables and track timelines with stakeholders.
• Participate in quality control reviews for documents by other authors.
• Serve as primary liaison with external publication editors and illustrators.
• Support study teams with review/editing of study documents and training materials.

Skills

Medical writing

Project management

Communication skills

GCP

GDPR

HIPAA

EndNote

Graphic software

Education

Undergraduate degree

Advanced degree preferred

Tools

EndNote

Job description

Alimentiv is seeking a Medical Writer to provide medical writing services and regulatory documentation support for Clinical Research Scientists, academics, sponsors, and internal teams. The role includes researching, writing, reviewing, and editing protocols, CSRs, ICFs, and reports, plus coordinating reviews and ensuring timely delivery.

You will manage writing deliverables, track timelines, perform quality control, and assist with training materials as needed, while applying GCP, GDPR, and