Medical Writer

Voronoi; Waltham (MA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

Voronoi is seeking an experienced Medical Writer with a strong background in oncology clinical trials to join our growing team. The ideal candidate will craft high-quality regulatory and scientific documents and collaborate with cross-functional groups to advance clinical development.

This remote or hybrid role requires familiarity with ICH guidelines, regulatory submissions, and effective scientific communication.

Qualifications

• Bachelor's degree in a scientific or healthcare discipline is required.
• 2+ 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.

Responsibilities

• Develop, write, and edit clinical and regulatory documents related to oncology clinical trials, including but not limited to: Clinical study protocols and amendments and CSRs; Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions.
• Collaborate with cross-functional teams to ensure content accuracy and consistency.
• Interpret and synthesize complex clinical data into clear, 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.

Skills

Medical writing

Regulatory writing

Scientific communication

Oncology knowledge

Education

Bachelor's degree in a scientific or healthcare discipline

Advanced degree preferred

Tools

MS Office Suite

Document management systems

Regulatory submission tools

Job description

Medical Writer - Oncology Clinical Trials

Location: Remote or Hybrid in Waltham, Massachusetts preferred. Candidates must be available to work within the Eastern Time Zone. Less than 5% travel required.

Position Summary

We are seeking an experienced Medical Writer with a strong background in oncology clinical trials to join our growing company. 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.

Key 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.
• 2+ 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
• Excellent written and verbal communication skills
• High attention to detail, strong analytical skills, and ability to manage multiple projects under tight deadlines
• Proficiency with document management systems and MS Office Suite; experience with templates and style guides
• Ability to work flexible hours. Internal team and study sites are spread across EU and Asia

Preferred Qualifications

• Experience working in a CRO, biotech, or pharmaceutical company
• Familiarity with submission processes (eCTD) and regulatory publishing
• Membership in professional organizations such as AMWA or EMWA is preferred