Principal Medical Writer - CMC Focus

📋 Description

• Lead and contribute to the development of high-quality regulatory documents across client
• Own and author key sections of regulatory submissions, including Module 3, such as Modules 3.2.S
• Lead project teams and coordinate contributors toward shared objectives while maintaining document
• Integrate and synthesize information from multiple data sources and documents to create clear
• Provide expert guidance on document preparation, review, comment resolution, incorporation of
• Apply knowledge of regulatory authority guidelines, development phases, and global regulatory

🎯 Requirements

• Bachelor's degree or higher, with a scientific discipline strongly preferred.
• 7+ years of regulatory writing experience, specifically involving Chemistry, Manufacturing, and
• Experience across areas such as vaccines, gene and cell therapy, biologics, small molecules
• Proven experience working on regulatory submissions such as NDAs, INDs, BLAs, or IMPDs, including
• Strong experience authoring and leading Module 3 documentation, including Modules 3.2.S and 3.2.P
• Strong understanding of global health authority requirements, regulatory guidelines, development

🎁 Benefits

• Fully remote working arrangement.
• Flexible paid time-off approach.
• Paid holidays are provided.
• Medical insurance, with benefits varying according to location.
• Access to retirement plans, depending on location.
• Tuition reimbursement may be available.