Remote Principal Medical Writer - CMC Submissions

Lever, Inc.; Canada; Remote; CAD 188,000 - 215,000; Full time

Benefits offered by this job

Remote Work

Flexible PTO

Paid Holidays

Healthcare

Retirement Plans

Tuition Reimbursement

Competitive Compensation

Global Team

Impactful Work

Job summary

Lever, Inc. in Canada seeks a Principal Medical Writer - CMC Focus to own complex CMC documentation and lead submission-level materials across global programs.

This senior role combines hands-on authorship with project leadership, mentoring colleagues and guiding regulatory strategy across biologics, vaccines, gene and cell therapies, and small molecules. Remote options available with high impact on timelines and quality.

Qualifications

• Bachelor's degree or higher in a scientific discipline.
• 7+ years regulatory writing experience in CMC.
• Experience across vaccines, gene/cell therapy, biologics, or small molecules.
• Experience on regulatory submissions (NDAs, INDs, BLAs, IMPDs).
• Strong knowledge of global health authority guidelines.
• Proficient MS Word with editing and formatting.
• Ability to lead projects and meet deadlines.
• Excellent communication and collaboration skills.
• Mentoring or leadership capabilities.

Responsibilities

• Lead regulatory document authoring for CMC across client engagements.
• Own and author sections of regulatory submissions (Module 3, 3.2.S, 3.2.P, 2.3).
• Coordinate project teams to meet timelines and budgets.
• Synthesize data into clear, scientifically sound regulatory content.
• Provide guidance on document preparation, review, and finalization.

Skills

CMC Expertise

Regulatory Writing

Submission Experience

Regulatory Knowledge

Leadership

Communication

Continuous Improvement

Technical Writing

Biologics & Vaccines

Cross-functional Collaboration

Education

Bachelor's degree or higher (scientific field)

Tools

Microsoft Word

Job description

Lever, Inc. in Canada seeks a Principal Medical Writer - CMC Focus to own complex CMC documentation and lead submission-level materials across global programs.

This senior role combines hands-on authorship with project leadership, mentoring colleagues and guiding regulatory strategy across biologics, vaccines, gene and cell therapies, and small molecules. Remote options available with high impact on timelines and quality.