Voronoi,Inc. Medical Writer; Hybrid Job Cambridge area,Massachusetts USA,Science

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

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

Medical Writer - Oncology Clinical Trials

Location: minimum 2 days onsite in Waltham, MA office Cambridge / Greater Boston

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:

Advanced degree (PhD, PharmD, MD, or MSc) in life sciences, medicine, or a related field
Minimum 5 years of medical writing experience, with at least 3 years focused on oncology clinical trials
In-depth understanding of oncology disease areas and clinical endpoints
Extensive 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

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

#J-18808-Ljbffr

Voronoi, Inc. Medical Writer; Hybrid