Medical Writer

Senior Medical Writer / Junior Medical Wirter - 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.

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