Senior Medical Writer

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

A growing oncology biotech in Cambridge, Massachusetts is progressing a NSCLC small molecule asset and they require a Medical Writer to support this asset and a number of early phase solid tumor trials. The ideal candidate will have a deep understanding of oncology therapeutic areas and a proven track record of preparing high-quality regulatory and scientific documents in support of clinical development programs. The company would prefer a hybrid worker but will consider a remote Medical Writer.

Responsibilities

• Develop, write, and edit clinical and regulatory documents related to oncology clinical trials, including but not limited to:
• Clinical study protocols and amendments
• Clinical study reports (CSRs)
• Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions
• Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and Safety teams to ensure content accuracy and consistency
• Interpret and synthesize complex clinical and scientific data into clear, concise, and scientifically sound documents
• Ensure all documents comply with ICH guidelines, regulatory requirements, and internal SOPs
• Participate in strategic planning and document timelines
• Mentor junior medical writers or contractors as needed
• Stay current with therapeutic area developments, industry trends, and regulatory guidance

Qualifications

• Bachelor's degree in a scientific or healthcare discipline required; advanced degree preferred.
• 5+ years of experience in medical writing, scientific writing, clinical research, regulatory affairs, or scientific communications.
• Experience in a CRO, biotechnology, pharmaceutical, or related life sciences environment preferred; equivalent experience will be considered.
• Demonstrated ability to analyze, interpret, and communicate scientific and clinical information effectively.
• In-depth understanding of oncology disease areas and clinical endpoints
• Experience in authoring documents for Phase I–III oncology trials and regulatory submissions
• Strong knowledge of ICH-GCP, FDA/EMA guidelines, and clinical trial processes