Medical Writer – Oncology Clinical Trials

Our Greater Boston area client is seeking an experienced Medical Writer with expertise in oncology clinical trials to support their growing clinical development programs.

What You’ll Do

• Author and edit oncology trial documents (protocols, CSRs, IBs, IND/CTA sections, NDAs/BLAs).
• Collaborate with clinical, regulatory, biostatistics, and safety teams.
• Translate complex data into clear, compliant documents.
• Ensure adherence to ICH-GCP, FDA/EMA guidelines, and SOPs.
• Mentor contractors/junior writers as needed.

What We’re Looking For

• Advanced degree (PhD, PharmD, MD, MSc).
• 5+ years medical writing, 3+ in oncology.
• Must have previous experience with clinical trial expansion plans, global study protocols, protocol amendments, and interim analysis reports.
• Strong knowledge of oncology endpoints and regulatory submissions.
• Excellent communication, detail orientation, and ability to manage deadlines.
• Proficiency with MS Office, document systems, and style guides.

Preferred

• CRO/biotech/pharma experience.
• Familiarity with eCTD submissions.
• AMWA/EMWA membership.