Medical Writer II, Oncology

Role: Medical Writer II, Regulatory Medical Writing supporting Oncology within Johnson & Johnson's Integrated Data Analytics & Reporting (IDAR) team. Primary objectives include authoring and coordinating clinical and regulatory documents such as protocols, CSRs, IB updates, and regulatory responses across early- and late-stage oncology programs. Responsibilities involve document preparation, quality checks, participating in cross-functional review meetings, and managing timelines. The role offers increasing independence with guidance, including mentoring junior staff and leading projects as experience develops. Requirements: a scientific degree (Master’s, PhD, MD preferred), 2+ years of pharmaceutical/scientific experience, 2-4+ years of regulatory medical writing, strong communication skills in English, and familiarity with ICH guidelines and industry standards. Preferred skills encompass collaboration, problem-solving, attention to detail, and knowledge of clinical research regulations, GxP, and industry tools. High-value specifics include oncology therapeutic area, regulatory document types (protocols, CSRs, IBs), and hybrid work setup (3 onsite days/week) across multiple international locations (US, UK, Belgium, Netherlands, Canada). The position involves interaction with internal cross-functional teams, external contractors, and external partners, emphasizing teamwork and project management in a regulated environment.