Principal Medical Writer – CMC
Trilogy
full-time
Posted on:
Location Type: Remote
Location: Canada
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Salary
💰 $154,000 - $163,900 per year
Job Level
About the role
- Write, edit, and review complex CMC regulatory documents, including Module 3 (Quality) of the eCTD, Quality Overall Summaries (QOS), and briefing books.
- Interpret and summarize technical data from analytical development, drug substance, and drug product manufacturing, ensuring consistency with regulatory standards.
- Ensure all documents adhere to ICH, FDA, and EMA regulations. Collaborate with Regulatory Affairs to develop submission strategies.
- Drive development of the CMC outputs by generating and reviewing CMC outputs from our medical writing platform and working with the AI development team to improve the quality of the outputs.
- Lead CMC writing teams, coordinating inputs from diverse departments such as Manufacturing, Quality Assurance, Regulatory Affairs, and CMC technical teams.
- Perform rigorous peer reviews and final quality checks on documents to ensure scientific accuracy, clarity, and grammatical correctness.
- Provide guidance, training, and mentorship to junior medical writers.
Requirements
- 5–10+ years of experience in medical writing, with a strong focus on CMC regulatory documentation.
- Minimum of a Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline.
- Deep understanding of ICH Guidelines, particularly for Module 3 (CMC).
- Excellent written and oral communication skills, with the ability to explain complex scientific concepts to diverse audiences.
- Strong ability to manage multiple, complex projects with shifting priorities.
- Expert knowledge of Microsoft Office Suite (Word, Excel) and Electronic Document Management Systems (eDMS).
Benefits
- Competitive base salary (range: $154,000 to $163,900 USD; the salary range is an estimate and may vary based on experience level, region, and the Company’s compensation practices)
- Annual bonus opportunity
- A generous allowance of paid time off (vacation, holiday, birthday, illness)
- An extended healthcare plan, dental coverage, life insurance, disability coverage, and voluntary accident & serious illness plans
- Retirement savings plan with company match
- Full AMWA membership and annual conference attendance paid for by Trilogy
- Continuous personal and professional development opportunities
- Free weekly yoga sessions
- Other fun and exciting events that encourage team bonding and development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingCMC regulatory documentationtechnical data interpretationpeer reviewquality checkssubmission strategiesproject management
Soft Skills
communication skillsmentorshipcollaborationleadershiporganizational skills