Associate Director, Regulatory Medical Writing, Oncology
Johnson & Johnson UK
High Wycombe, United Kingdom
Fully remote
Regulatory medical writing
Oncology drug development
Clinical and regulatory documents
Lead in setting functional tactics/strategy and project-level strategy for submissions, global programs, and clinical teams
Job Summary
Lead in setting functional tactics/strategy and project-level strategy for submissions, global programs, and clinical teams.
Responsible for writing and coordinating complex clinical and regulatory documents, championing internal standards and guidelines.
Supervise and manage a team of internal medical writers, ensuring quality deliverables and compliance, while participating in hiring and development discussions.
Matching Summary
Lead in setting functional tactics/strategy and project-level strategy for submissions, global programs, and clinical teams.
Skills & Requirements
Must-have
Regulatory Medical Writing
Oncology drug development
Clinical and regulatory documents
ICH guidelines
People management experience
Nice-to-have
Cross-functional collaboration
Process improvement leadership
Mentoring junior writers
Industry standards knowledge
Act as change agent
Key Requirements
Bachelor's Degree required
10+ years pharmaceutical/scientific experience
8+ years clinical/regulatory medical writing experience
2+ years people management experience
Advanced knowledge of regulatory guidance documents