Medical Writer Job at Navigator Medicines, Inc. in Boston

The role

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.

The problems you'll work on

• Translating complex clinical, statistical, and regulatory inputs into clear, compliant, and high‑quality documents
• Managing multiple document timelines and review cycles across Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations
• Ensuring consistency, accuracy, and regulatory compliance across protocols, IBs, CSRs, ICFs, SAPs, and regulatory summaries
• Supporting IND and CTA submissions, amendments, and inspection readiness in a resource‑lean environment
• Maintaining document quality, version control, and inspection‑ready standards as programs scale

What you'll learn

• How early‑stage biotech companies build and execute clinical development programs from the ground up
• End‑to‑end exposure to regulatory submissions and health authority interactions
• How cross‑functional teams collaborate to move programs efficiently through clinical milestones
• How to balance speed, rigor, and compliance in a growing clinical organization

How we work

• We value clarity, accuracy, and regulatory rigor
• We operate with high ownership and close collaboration across functions
• We move quickly while maintaining patient safety and data integrity as top priorities
• We expect Medical Writing to be a strategic partner, not just a documentation function
• We build systems that scale while staying hands‑on

What you bring

• Bachelor's degree in life sciences or a related field (advanced degree preferred)
• 3–7+ years of medical writing experience in biotech, pharma, or CRO settings
• Proven experience authoring clinical and regulatory documents (protocols, IBs, CSRs, ICFs, SAPs, regulatory summaries)
• Strong understanding of clinical development processes and global regulatory requirements (ICH, GCP, FDA, EMA)
• Excellent writing, organizational, and collaboration skills
• Experience working in early‑stage or small biotech environments preferred

About Navigator Medicines

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.

Navigator Medicines is committed to improving the lives of patients with heterogeneous conditions through cutting‑edge science and groundbreaking advancements in immune therapeutics.

Legal & Equal Opportunity Notice

Navigator Medicines is an equal opportunity employer and provides reasonable accommodations as required by Massachusetts and California law.