Avetix Engineering

Associate Director, Health Authorities (Medical Writing Leadership) | Summit, NJ Job Type: Full time permanent Location: Onsite, Summit, NJ Company Overview: A vertically integrated, commercial-stage biopharmaceutical company developing next-generation immunotherapies and cell therapies for cancer and infectious disease. They already have an FDA-approved, Breakthrough Therapy-designated product on the market and a growing pipeline behind it. This is a genuinely collaborative, cross-functional environment with real investment in professional development. This isn't a "write and file" role. You'll be leading a team, owning the clinical narrative across INDs, CTAs, BLAs and MAAs, and acting as the final quality gate before documents go to Health Authorities. Responsibilities Lead and develop a team of Health Authorities writers/specialists, including hiring, coaching and performance management Author and review clinical sections for INDs, CTAs, NDAs, BLAs and MAAs Own end-to-end...