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