Technical Writer – CMC Submissions
Meet Life SciencesSan Rafael, California, United States4 hours ago
Job type
- Full-time
Job descriptionBachelor’s degree in life sciences, chemistry, biochemistry, or a related field (advanced degree preferred). Demonstrated experience in authoring regulatory documents, preferably CMC sections of health authority submissions. Excellent written and verbal communication skills with strong attention to detail. Ability to understand, analyze, and clearly present complex scientific and technical information. Strong organizational skills and ability to manage multiple projects under tight deadlines. Proficiency in Microsoft Office and document management systems; familiarity with eCTD submissions is a plus.
Job Title : Technical Writer – CMC Submissions
Job Summary :
We are seeking a highly skilled Technical Writer to support Chemistry, Manufacturing, and Controls (CMC) regulatory submissions. The successful candidate will be responsible for authoring CMC content, coordinating cross-functional reviews, and leading the adjudication and finalization process to ensure delivery of high-quality, submission-ready dossiers to health authorities.
Key Responsibilities :
- Author CMC regulatory content in alignment with global submission requirements.
- Initiate and manage review cycles, ensuring timely feedback from subject matter experts and stakeholders.
- Lead comment adjudication and finalization activities to deliver accurate, compliant submission documents.
- Collaborate with cross-functional teams, including Regulatory Affairs, Quality, and Technical Operations, to gather and interpret complex scientific information.
- Ensure consistency, clarity, and compliance with regulatory and company standards across all written materials.
- Maintain awareness of current regulatory guidelines and industry best practices to support high-quality submission development.
Qualifications & Skills :
Create a job alert for this search
Technical Writer • San Rafael, California, United States