Regulatory Medical Writer & Project Lead

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

Job summary

Alimentiv in London, Ontario, is seeking a medical writing specialist to provide writing and consultation to Clinical Research Scientists, Academic partners, Sponsors and/or the corporation. You will research, write, review, edit scientific information, coordinate reviews, conduct reference searches and translate data into regulatory documents and presentations.

The role requires leading regulatory documents production, coordinating with authors, tracking timelines, ensuring QA, and supporting

Qualifications

• Minimum of an undergraduate degree (advanced degrees preferred) and 3-5 years of relevant experience in medical writing.
• Experience leading the development of protocols, ICFs, and CSRs.
• Trained in GCP, GDPR, and HIPAA.
• Advanced knowledge of EndNote/reference software.

Responsibilities

• Lead the content planning and production of regulatory documents (protocols, Investigator's Brochure, CSRs, ICFs, etc.).
• Coordinate with authors/technical specialists to translate, write, edit and proof data for publication.
• Act as project manager for writing deliverables and track timelines for stakeholders.
• Participate in quality control review for documents written by other authors.

Skills

Medical writing

Project management

Written communication

Adaptability

Diplomacy

Education

Undergraduate degree

Advanced degree preferred

Tools

EndNote

Job description

Alimentiv in London, Ontario, is seeking a medical writing specialist to provide writing and consultation to Clinical Research Scientists, Academic partners, Sponsors and/or the corporation. You will research, write, review, edit scientific information, coordinate reviews, conduct reference searches and translate data into regulatory documents and presentations.

The role requires leading regulatory documents production, coordinating with authors, tracking timelines, ensuring QA, and supporting