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