Manager, Japan Medical Writing & Regulatory Medical Writing

About the role

Johnson & Johnson's Innovative Medicine business is hiring a Manager for Japan Medical Writing and Regulatory Medical Writing in its Medical Affairs group, based in Chiyoda, Tokyo. The role is a lead writer who writes and coordinates clinical and regulatory documents across therapeutic areas, works in a team and matrix environment, and may supervise external contractors.

Key responsibilities

• Write or coordinate all types of clinical and regulatory documents, taking a proactive or lead role in content and scientific strategy
• Lead or set objectives for team projects and tasks, including process working groups and Communities of Practice
• Act as lead writer on any compound or submission, and as primary point of contact for medical writing activities with the cross-functional team
• Guide and train cross-functional team members, coach and mentor junior writers, and provide peer review
• Lead document planning and review meetings, establish document timelines and strategies, and recommend process improvements
• Complete time reporting, training and metrics updates in company systems
• Represent medical writing in industry standards working groups and oversee day-to-day work of contractors or external partners

Required profile

• University or college degree in a scientific discipline; an advanced degree (Masters, PhD, MD) is preferred
• At least 8 years of relevant pharmaceutical or scientific experience
• At least 6 years of clinical or regulatory medical writing experience
• 0-2 years of people management experience if a people manager
• Excellent oral and written communication, attention to detail, strong leadership and time management skills, and solid knowledge of regulatory guidance such as ICH requirements