Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated based in the United States.

This is a senior regulatory medical writing opportunity supporting clinical development programs in a sponsor-dedicated environment.

You’ll lead the development of high-quality regulatory and clinical documents across Phase 2 and Phase 3 studies.

The role spans key deliverables including protocols, CSRs, investigator brochures, submission documents, and integrated safety and efficacy summaries.

You’ll work closely with cross-functional experts across biostatistics, regulatory affairs, medical affairs, and data management.

As a senior subject-matter expert, you’ll help ensure scientific accuracy, regulatory compliance, consistency, and timely delivery.

The position combines hands-on writing with project leadership, client collaboration, peer review, mentoring, and process improvement.

This is a remote role open to candidates in the United States, with limited travel expected.