Associate Director Medical Writing

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 submission packages, from first draft through to final eCTD-ready documentation Manage Health Authority RFI responses, coordinating CROs, external consultants and KOLs to gather data and craft high quality responses Set the standard across the function: SOPs, templates, QC processes and version control governance for a centralised document repository Monitor evolving global and regional regulatory guidance and translate updates into practical submission strategy Build and maintain product development roadmaps aligned to projected approval dates Partner cross-functionally on the design, review and reporting of sponsored clinical studies Requirements Life sciences or technical degree with 10+ years' relevant experience; or Master's with 8+ years; or Doctorate with 6+ years Proven people management experience — this is a leadership seat, not just a technical one Hands-on experience managing and preparing clinical module submissions in eCTD format Medical writing experience essential Experience organising and managing responses to Health Authority information requests Regulatory submission experience outside the US preferred Based on-site in Summit, NJ, Monday to Friday, with some flexibility available with manager approval #J-18808-Ljbffr Avetix Engineering