Ayumi M.
Project Lead @Johnson & Johnson Innovative Medicine
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WORK HISTORY
Project Lead @Johnson & Johnson Innovative Medicine
Internal Project Management in Process Transformation Using AI Tools and Organisational Governance / Approval / Compliance within the Document Management Group - Regulatory Writing Department (P6/Senior Analyst Level)- Lead the transformation of the IB (Investigator’s Brochure) translation process by implementing AI-assisted tool (Language Weaver), optimizing vendor workflows, and establishing new KPIs for regulatory documentation- Own end-to-end regulatory writing process within the Document Management Group and the Publication Owner Office, managing third-party vendors and CRO oversight for timely, compliant deliverables- Drive standardization of high-quality documentation workflows across functions- Operational-side user of RIMdocs, supporting regulated document lifecycles in GxP environments- Ensured compliance with regulatory and quality requirements through controlled document management processes
EDUCATION
Hochschule für Technik und Wirtschaft Berlin
Master of Business Administration and Engineering - MBA&E, Life Science Management
University of Leeds
Master of Arts (MA), British History - Eighteenth Century Studies
Kokushikan University
Bachelor of Arts (BA), Japanese History and Archaeology
ABOUT AYUMI M.
Over 12 years of experience in the pharmaceutical industry, covering GCP areas such as pharmacovigilance, medical writing, and clinical operations, as well as GMP contract biosafety testing.Specialises in global project management, leading initiatives across Japan, APAC, the UK, and the US. Recent relocation to Berlin expanded international exposure and strengthened ability to contribute diverse perspectives to the European market.Since Aug 2025, working as a Project Lead, responsible for process transformation using AI tools within the Document Management Group in the Regulatory Writing Department at J&J/Janssen Pharmaceuticals (P6/Senior Analyst Level).
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