Oncology Medical Writer - Hybrid (Regulatory Submissions)
VORONOI, Inc.
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. #J-18808-Ljbffr VORONOI, Inc.
Vacancy posted 4 days ago
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