voronoiWaltham, MA
Senior Medical Writer
Senior Medical Writer
Senior Medical Writer
voronoiWaltham, MA
2 days ago
Research and Development in BiotechnologyResearch and Development in the Physical, Engineering, and Life SciencesSpecialty Hospitals
Apply for this role (opens in a new tab)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
- 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 SOPsParticipate 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
Also on the board Same function, level within a rung
Level
Senior
Location
Waltham, MA
Occupation
Writers and Authors
Industry
Research and Development in Biotechnology
Posted
2 days ago