Principal Medical Writer - CMC Focus

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 United States . 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.