Oncology Medical Writer - Hybrid (Regulatory Submissions)

VORONOI, Inc.; Cambridge (MA); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Voronoi, Inc. is seeking an experienced Medical Writer with a strong background in oncology clinical trials.

This hybrid role requires minimum 2 days onsite in Waltham, MA / Cambridge area, supporting regulatory and scientific documents for oncology programs. The candidate will write, edit, and manage sections of regulatory submissions, while mentoring junior writers and aligning with ICH-GCP guidelines and SOPs.

Qualifications

• Advanced degree in life sciences or related field.
• 5+ years medical writing experience, with 3+ years in oncology.
• Experience with Phase I–III oncology trials & regulatory submissions.
• Strong knowledge of ICH-GCP and FDA/EMA guidelines.
• Excellent written and verbal communication; attention to detail.

Responsibilities

• Develop, write, and edit clinical and regulatory documents for oncology trials.
• Prepare protocols, CSRs, IBs, informed consent forms, and briefing documents.
• Contribute to regulatory submissions (INDs, NDAs, BLAs) and timelines.
• Collaborate with cross-functional teams to ensure accuracy and consistency.
• Mentor junior medical writers and stay current with guidance and trends.

Skills

Medical writing

Oncology knowledge

Regulatory writing

ICH-GCP knowledge

Project management

Editorial rigor

Education

PhD/MD/PharmD/MSc in life sciences or related

Tools

MS Office Suite

Document management systems

Job description

Voronoi, Inc. is seeking an experienced Medical Writer with a strong background in oncology clinical trials.

This hybrid role requires minimum 2 days onsite in Waltham, MA / Cambridge area, supporting regulatory and scientific documents for oncology programs. The candidate will write, edit, and manage sections of regulatory submissions, while mentoring junior writers and aligning with ICH-GCP guidelines and SOPs.