[Voronoi, Inc.] Senior Medical Writer (Hybrid Work)

Senior 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

- Investigator brochures

- Clinical study reports (CSRs)

- Informed consent forms

- Briefing documents

- 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

- 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