Associate Director, Regulatory Medical Writing, Oncology

Johnson & Johnson UK

Beerse, Belgium
Fully remote
Regulatory medical writing
Oncology therapeutic area
Lead complex documents independently
Able to function as a lead writer on any compound independently and lead project-level strategy

Job Summary

  • Able to function as a lead writer on any compound independently and lead project-level strategy.
  • Responsible for leading compound/submission/indication/disease area writing teams independently and guiding cross-functional team members on processes and best practices.
  • Supervises/manages and is accountable for direct reports, including setting objectives, providing performance oversight, and participating in hiring and development discussions.

Matching Summary

Able to function as a lead writer on any compound independently and lead project-level strategy.

Skills & Requirements

Must-have

  • Regulatory Medical Writing
  • Oncology therapeutic area
  • Lead complex documents independently
  • People management experience
  • Clinical and regulatory documents

Nice-to-have

  • Champion internal standards
  • Improve internal systems and processes
  • Lead process working groups
  • Oversee external contractors
  • 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 ICH requirements

Work Rights

Not specified

Tailored Resume

Cover Letter