What are the responsibilities and job description for the Senior Medical Writer position at LS Solutions?
Role: Medical Writer, Immuno-Oncology
Duration: Waltham, MA
Duration: 4 Months
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)
Salary : $65 - $75
