Senior Oncology Medical Writer (Regulatory & Trial Documentation)

Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment; Massachusetts; Hybrid; USD 110,000 - 140,000; Full time

Job summary

Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment is seeking a Medical Writer for an oncology-focused asset in Cambridge, MA. The role involves preparing regulatory and scientific documents for Phase I–III oncology trials, with collaboration across Clinical Development, Regulatory, Biostatistics, Data Management, and Safety teams.

The ideal candidate has 5+ years in medical writing or regulatory affairs in biotech/pharma, strong oncology knowledge, and a track record of producing

Qualifications

• Deep understanding of oncology areas and clinical endpoints.
• Track record of preparing high-quality regulatory and scientific documents.
• Experience in CRO/biotech/pharma environments preferred.

Responsibilities

• Develop, write, and edit clinical and regulatory documents for oncology trials.
• Prepare CSRs, protocols, amendments, and sections of INDs/NDAs/BLAs.
• Collaborate with cross-functional teams to ensure accuracy and consistency.
• Interpret complex data into clear scientific narratives.
• Ensure documents comply with ICH guidelines, FDA/EMA guidelines, and SOPs.
• Mentor junior writers or contractors as needed.

Skills

Oncology knowledge

Regulatory writing

Scientific writing

Clinical development

Regulatory knowledge

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment is seeking a Medical Writer for an oncology-focused asset in Cambridge, MA. The role involves preparing regulatory and scientific documents for Phase I–III oncology trials, with collaboration across Clinical Development, Regulatory, Biostatistics, Data Management, and Safety teams.

The ideal candidate has 5+ years in medical writing or regulatory affairs in biotech/pharma, strong oncology knowledge, and a track record of producing