Manager Medical Writing XTA

Role: Manager, Regulatory Medical Writing supporting key therapeutic areas within Johnson & Johnson's Integrated Data Analytics & Reporting (IDAR). Objectives include preparing all clinical documentation, leading medical writing projects, and guiding cross-functional teams. Responsibilities involve content development, project leadership, process optimization, and mentoring junior staff, with potential involvement in submission teams and industry standards groups. Qualifications: University degree (Master's/PhD preferred), minimum 8 years in pharma/scientific fields, with at least 6 years in medical writing and submission leadership experience. Experience across multiple therapeutic areas and regulatory guidance knowledge (e.g., ICH) are valued. Skills required include medical/regulatory writing, project management, and cross-functional collaboration; preferred skills encompass clinical research, process improvement, and industry analysis. High-value specifics: focus on clinical documentation for pharmaceutical products across various therapeutic areas, with experience in submission management and regulatory compliance. Work setup: Hybrid (3 days onsite weekly) in locations such as US, UK, Netherlands, Germany, France, Belgium; remote options considered. Travel requirements are not explicitly stated.