Director Medical Writing Asset Lead, Oncology

GlaxoSmithKline

Multiple Locations
Base: pln 0; bonus/equity: not specified; benefits...
Oncology asset medical writing strategy
Clinical document authoring and delivery
Global regulatory interactions and submissions
Lead medical writing for oncology assets, shaping regulatory strategy and delivering high-quality clinical documents for global interactions and submissions

Job Summary

  • Lead medical writing for oncology assets, shaping regulatory strategy and delivering high-quality clinical documents for global interactions and submissions.
  • Own and drive asset-level medical writing strategy, aligning with development and regulatory objectives, and leading multi-disciplinary teams and external vendors.
  • Drive process and technology improvements to increase consistency, efficiency, and document quality, while mentoring colleagues and building oncology medical writing capability.

Matching Summary

Lead medical writing for oncology assets, shaping regulatory strategy and delivering high-quality clinical documents for global interactions and submissions.

Salary

Base: PLN 0; Bonus/Equity: Not specified; Benefits: Statutory benefits, private healthcare, additional paid days off, life insurance, private pension plan, parental leave

Skills & Requirements

Must-have

  • Oncology asset medical writing strategy
  • Clinical document authoring and delivery
  • Global regulatory interactions and submissions
  • Lead matrix teams and vendors
  • Program management and risk identification

Nice-to-have

  • Collaborative leadership
  • Practical problem solving
  • Inclusive coaching
  • Agile working culture
  • Process and technology improvements

Key Requirements

  • Postgraduate degree in life sciences or related discipline
  • Significant experience in clinical regulatory medical writing
  • Experience authoring oncology regulatory documents for FDA/EMA
  • Experience leading matrix teams and managing vendors
  • Program management and risk identification skills

Work Rights

Not specified

Tailored Resume

Cover Letter