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.