Principal Medical Writer - CMC Focus

Jobgether SRL; Canada; Remote; CAD 188,000 - 215,000; Full time

Benefits offered by this job

Remote Work

Flexible PTO

Paid Holidays

Healthcare

Retirement Plan

Tuition Support

Global Environment

Impactful Work

Job summary

Partner Company in Canada seeks a Principal Medical Writer - CMC Focus with 7+ years of regulatory writing experience to lead high‑quality CMC documentation for regulatory submissions.

You will own submission sections (Module 3; 3.2.S, 3.2.P, 2.3), mentor writers, and influence document quality, strategy, and timelines across biologics, vaccines, gene therapy, and small molecules in a globally connected environment.

Qualifications

• 7+ years of regulatory writing experience, specifically involving Chemistry, Manufacturing, and Controls documentation.
• Strong knowledge of global regulatory requirements and submission practices.
• Experience authoring Module 3, including 3.2.S and 3.2.P, and Module 2.3.

Responsibilities

• Lead and contribute to regulatory documents focused on CMC for submissions.
• Own key sections of regulatory submissions (Module 3, 3.2.S, 3.2.P, 2.3).
• Lead project teams, coordinate contributors, manage timelines and budgets.
• Synthesize data from multiple sources into clear regulatory content and summaries.
• Provide guidance on document quality, reviews, and finalization for submission readiness.
• Mentor and share regulatory writing expertise across the team.
• Build client relationships and contribute to effective delivery across engagements.

Skills

Regulatory writing

Project leadership

Communication

Mentoring

Regulatory knowledge

Time management

Education

Bachelor's degree in science

Tools

Microsoft Word

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Medical Writer - CMC Focus based in Canada.

This is a senior regulatory writing role focused on creating high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions.

You will take ownership of complex, submission-level documents while contributing to engagements across different development programs and therapeutic areas.

The role combines hands-on authorship with project leadership, requiring strong scientific judgment and an understanding of global regulatory expectations.

You will work across areas such as biologics, vaccines, gene and cell therapy, small molecules, manufacturing, analytical development, and stability.

The position offers significant influence over document quality, submission strategy, timelines, and successful health authority interactions.

You will also mentor colleagues, provide subject matter guidance, and help strengthen regulatory writing practices across the organization.

The environment is collaborative, flexible, and globally connected, with the opportunity to contribute to therapies intended to improve patients' lives.

Accountabilities

• Regulatory Document Authoring: Lead and contribute to the development of high-quality regulatory documents across client engagements, with a particular focus on CMC documentation and submission-level materials.
• CMC Submission Leadership: Own and author key sections of regulatory submissions, including Module 3, such as Modules 3.2.S and 3.2.P, and Module 2.3.
• Project Leadership: Lead project teams and coordinate contributors toward shared objectives while maintaining document quality, timelines, and budget expectations for complex engagements.
• Scientific Synthesis: Integrate and synthesize information from multiple data sources and documents to create clear, accurate, and scientifically sound regulatory content and summary reports.
• Quality & Review: Provide expert guidance on document preparation, review, comment resolution, incorporation of feedback, and finalization of submission-ready materials.
• Regulatory Strategy: Apply knowledge of regulatory authority guidelines, development phases, and global regulatory pathways to anticipate how writing practices and document decisions may affect regulatory review and acceptance.
• Mentoring & Knowledge Sharing: Coach and mentor other writers, promote effective communication and working practices, and transfer regulatory writing expertise to strengthen capabilities across the wider team.
• Client Collaboration: Build professional relationships with clients, support ongoing business relationships, maintain current industry knowledge, and contribute to effective delivery across engagements.

Requirements

• Education: Bachelor's degree or higher, with a scientific discipline strongly preferred.
• Regulatory Writing Experience: 7+ years of regulatory writing experience, specifically involving Chemistry, Manufacturing, and Controls documentation.
• Therapeutic & Technical Expertise: Experience across areas such as vaccines, gene and cell therapy, biologics, small molecules, manufacturing, analytical development, or stability.
• Submission Experience: Proven experience working on regulatory submissions such as NDAs, INDs, BLAs, or IMPDs, including document-lead responsibilities for submission-level materials.
• CMC Expertise: Strong experience authoring and leading Module 3 documentation, including Modules 3.2.S and 3.2.P, as well as Module 2.3.
• Regulatory Knowledge: Strong understanding of global health authority requirements, regulatory guidelines, development phases, and different regulatory pathways.
• Technical Writing Skills: Intermediate Microsoft Word proficiency, including editing tools, table creation and modification, figure insertion, and document management techniques.
• Leadership & Organization: Demonstrated ability to manage complex projects, prioritize effectively, meet deadlines, resolve sensitive or high‑pressure issues, and maintain strong organizational and time‑management practices.
• Communication & Collaboration: Excellent communication skills, with the ability to coach others, build professional relationships, resolve feedback effectively, and guide multidisciplinary contributors toward common goals.
• Continuous Improvement: Ability to identify effective working practices, promote consistency, apply lessons learned, and actively share knowledge to improve organizational capabilities.

Benefits

• Remote Work: Fully remote working arrangement.
• Flexible Time Off: Flexible paid time‑off approach.
• Paid Holidays: Paid holidays are provided.
• Healthcare: Medical insurance, with benefits varying according to location.
• Retirement: Access to retirement plans, depending on location.
• Tuition Support: Tuition reimbursement may be available.
• Compensation: Estimated US hiring range of $132,000–$151,000 plus applicable bonus; compensation for Canada and other regions varies according to local market data, skills and experience, education, certifications, location, and other relevant factors.
• Global & Inclusive Environment: Opportunity to work with a globally distributed team in a flexible and inclusive culture.
• Professional Impact: Meaningful opportunity to contribute to regulatory submissions supporting the development and approval of life‑changing therapies.