Manager Medical Writing XTA

Role: Manager, Regulatory Medical Writing supporting key therapeutic areas within Johnson & Johnson's Integrated Data Analytics & Reporting (IDAR) business. Responsibilities: prepare and finalize clinical documents, lead and coordinate cross-functional teams, set objectives, guide junior staff, and ensure compliance with regulatory guidelines. May lead program-level writing teams and represent Medical Writing in industry standards groups. Requirements: university degree (Master’s/PhD preferred), minimum 8 years of pharmaceutical/scientific experience, at least 6 years in medical writing, with submission leadership experience advantageous. High-Value: expertise across multiple therapeutic areas, familiarity with regulatory documents, ICH guidelines, and clinical trial processes. Work setup: hybrid model (3 days onsite weekly) across multiple European and US locations with potential remote options; travel as needed.