Medical Writer

<p><strong>The role</strong></p> <p>Navigator Medicines is building an immunology-first biotech focused on bispecific drug discovery for immunology and inflammatory diseases. As a Medical Writer, you will play a critical hands-on role supporting clinical development by authoring and coordinating high-quality clinical and regulatory documents across multiple programs. This role is ideal for a Medical Writer who thrives in a small, fast-moving biotech environment and wants broad ownership, close cross-functional collaboration, and meaningful impact on advancing clinical programs.</p> <p><strong>The problems you’ll work on</strong></p> <ul> <li>Translating complex clinical, statistical, and regulatory inputs into clear, compliant, and high-quality documents</li> <li>Managing multiple document timelines and review cycles across Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations</li> <li>Ensuring consistency, accuracy, and regulatory compliance across protocols, IBs, CSRs, ICFs, SAPs, and regulatory summaries</li> <li>Supporting IND and CTA submissions, amendments, and inspection readiness in a resource-lean environment</li> <li>Maintaining document quality, version control, and inspection-ready standards as programs scale</li> </ul> <p><strong>What you’ll learn</strong></p> <ul> <li>How early-stage biotech companies build and execute clinical development programs from the ground up</li> <li>End-to-end exposure to regulatory submissions and health authority interactions</li> <li>How cross-functional teams collaborate to move programs efficiently through clinical milestones</li> <li>How to balance speed, rigor, and compliance in a growing clinical organization</li> </ul> <p><strong>How we work</strong></p> <ul> <li>We value clarity, accuracy, and regulatory rigor</li> <li>We operate with high ownership and close collaboration across functions</li> <li>We move quickly while maintaining patient safety and data integrity as top priorities</li> <li>We expect Medical Writing to be a strategic partner, not just a documentation function</li> <li>We build systems that scale while staying hands-on</li> </ul> <p><strong>What you bring</strong></p> <ul> <li>Bachelor’s degree in life sciences or a related field (advanced degree preferred)</li> <li>3–7+ years of medical writing experience in biotech, pharma, or CRO settings</li> <li>Proven experience authoring clinical and regulatory documents (protocols, IBs, CSRs, ICFs, SAPs, regulatory summaries)</li> <li>Strong understanding of clinical development processes and global regulatory requirements (ICH, GCP, FDA, EMA)</li> <li>Excellent writing, organizational, and collaboration skills</li> <li>Experience working in early-stage or small biotech environments preferred</li> </ul> <p>The salary range for this position is expected to be between $175,000 and $190,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.</p> <p><strong>About Navigator Medicines</strong></p> <p>Navigator Medicines is a clinical-stage biopharmaceutical company dedicated to advancing biologics for targeted immune regulation and restoration. Founded in 2024 as a subsidiary of Sera Medicines with $100M Series A financing co-led by RA Capital Management and Forbion, the company focuses on developing innovative therapies for complex autoimmune diseases.</p> <p>Navigator Medicines is committed to improving the lives of patients with heterogeneous conditions through cutting-edge science and groundbreaking advancements in immune therapeutics.</p> <p><strong>Legal & Equal Opportunity Notice</strong></p> <p>Navigator Medicines is an equal opportunity employer and provides reasonable accommodations as required by Massachusetts and California law.</p> <p> </p> <p> </p>