Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated
About the role
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.
Responsibilities
- Lead the preparation and delivery of clear, scientifically accurate, and regulatory-compliant medical writing deliverables across individual studies and broader clinical development programs.
- Develop and oversee