Principal Medical Writer - CMC Focus

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.