Job Description

Job Title: Medical Writer, Immuno-Oncology

Location: Waltham, MA (On-Site)

3-4 months Contract - (chance to extend based on project)

JOB DESCRIPTION:

Overview:

Our client is a small Boston-based clinical-stage biotechnology company dedicated to developing next-generation immunotherapies for cancer and autoimmune diseases. Leveraging deep expertise in biologics, the company designs proprietary biotherapeutics with tissue- and cell-specific targeting, bispecific formats, and novel masking technologies for precision drug delivery.

They are seeking a Medical Writer to support a Pre-IND submission and related documentation for a first-in-class immunotherapy program targeting solid tumors. This contract role will focus on authoring and reviewing regulatory documents, research manuscripts, and technical summaries in collaboration with R&D leadership and external partners. The position reports directly to the EVP of R&D and will work closely with scientific leads, project management, and external CROs.

Responsibilities:

• Author high-quality Pre-IND/IND documents, including:
• Investigator’s Brochure (IB)
• Clinical Study Plans
• CTD Modules 2, 4, and 5
• Preclinical and nonclinical summaries
• Research manuscripts, congress abstracts, and posters
• Translate complex data from preclinical, nonclinical, and clinical studies into clear and accurate content for technical, medical, and regulatory audiences
• Collaborate with internal teams and external partners to interpret data and refine scientific messaging
• Review and revise study protocols and supporting documentation created by internal teams
• Lead internal and external review cycles for core documents, resolving comments and preparing materials for submission
• Ensure all regulatory documents meet FDA/ICH standards and are audit-ready
• Support the development of standardized templates for research documentation and manuscripts
• Maintain consistency in scientific messaging across all written materials

Requirements:

• PhD preferred; MS required in Immunology, Immuno-Oncology, or a related life sciences discipline
• 8–10 years of medical/scientific writing experience in the biotech or pharmaceutical industry
• Strong experience with immunotherapies, particularly bispecific antibodies or monoclonal antibodies
• Familiarity with CTD format (Modules 2, 4, 5) and regulatory writing conventions
• Proven ability to lead document preparation from draft to final, including QC and peer review
• Comfortable managing multiple deliverables in a fast-paced, cross-functional environment
• Excellent writing, editing, and data interpretation skills
• Must be commutable to Waltham, MA — hybrid presence required (onsite expectations vary week to week; no relocation considered)

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