Remote QC Medical Writer — Oncology Regulatory Docs

Sumitomo Pharma; Cheyenne (WY); On-site; USD 101,000 - 126,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Paid holidays

Job summary

Sumitomo Pharma Co., Ltd. is seeking a QC Medical Writer for a US remote role within the Medical Writing Function. The role focuses on QC audits of clinical regulatory documents and coordinating with the team to address findings, maintaining company standards.

Reporting to the Executive Director, Medical Writing Oncology, you will support document reviews, templates, SOPs, and timely delivery of high-quality study documents (protocols, amendments, and study reports) across programs.

Qualifications

• Minimum 3 years of QC experience in biotech/pharma
• Experience with AMA style and document templates
• Working knowledge of GCP, FDA regulations, ICH guidelines

Responsibilities

• QC review of clinical regulatory documents
• Collaborate with Medical Writing team to address QC findings
• Ensure consistent style and adherence to company standards
• Assist in the development of templates and SOPs
• Assist in producing high-quality, on-time writing deliverables

Skills

Communication skills

Attention to detail

Adaptable

Education

Bachelor’s Degree or equivalent

Job description

Sumitomo Pharma Co., Ltd. is seeking a QC Medical Writer for a US remote role within the Medical Writing Function. The role focuses on QC audits of clinical regulatory documents and coordinating with the team to address findings, maintaining company standards.

Reporting to the Executive Director, Medical Writing Oncology, you will support document reviews, templates, SOPs, and timely delivery of high-quality study documents (protocols, amendments, and study reports) across programs.