Title: Principal Regulatory Medical Writer – REMOTE

Company: Jobgether
Location: Canada
Job Type: FlexTime, FullTime


Apply Now


Description:

This position is for a Principal Regulatory Medical Writer posted by Jobgether on behalf of a partner company. The role involves leading the development of complex clinical regulatory documents for a key strategic client in the pharmaceutical industry. By serving as a core team member, you will impact bringing life-changing treatments to patients faster and have the opportunity to engage deeply with high-profile clients in a collaborative environment.

Accountabilities

  • Serve as a subject-matter expert on global clinical and regulatory writing projects
  • Lead the writing, review, and coordination of complex documents, including CTD Modules and Clinical Study Protocols
  • Drive development of key clinical documents that align with overall program and submission strategy
  • Provide strategic input that shapes messaging, data presentation, and regulatory positioning
  • Lead and manage complex medical writing projects across cross-functional teams
  • Coordinate stakeholders, facilitate discussions, and support timely decision-making throughout the document lifecycle
  • Requirements

  • Bachelor's degree in life science
  • Advanced degree (PhD or Master's) in a life science discipline preferred
  • Minimum 6 years of eCTD submission medical writing experience, including 3+ years as a project lead
  • Extensive experience leading development of clinical summaries and regulatory submission documents
  • Proven ability to guide cross-functional stakeholders through complex submission development
  • Deep understanding of global regulatory expectations and clinical development
  • Benefits

  • Opportunity for hands-on engagement with science and high-profile clients
  • Support for deep technical expertise and training for leadership roles
  • Flexible work environment accommodating remote work
  • Engagement in meaningful work that impacts patient care
  • Why Apply Through Jobgether?

    We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

    We appreciate your interest and wish you the best!

    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

    #LI-CL1


    Apply Now  



    Magazica AI Resume Analyzer

    Compare your resume with this job and get a personalized report.

    ⚠️ Please Sign in to use the Resume Analyzer.