Director Medical Writing Asset Lead, Oncology

GSK

Base: pln 0 to pln 0 gross; bonus/equity: not spec...
Oncology asset medical writing strategy
Clinical regulatory medical writing
Authoring global oncology submissions
Lead strategy, planning, authoring and delivery of clinical documents across the asset lifecycle, including clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions

Job Summary

  • Lead strategy, planning, authoring and delivery of clinical documents across the asset lifecycle, including clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions.
  • Own and drive asset-level medical writing strategy, ensuring alignment with development and regulatory objectives across regions.
  • Drive process and technology improvements that increase consistency, efficiency and document quality while constructively challenging the status quo.

Matching Summary

Lead strategy, planning, authoring and delivery of clinical documents across the asset lifecycle, including clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions.

Salary

Base: PLN 0 to PLN 0 gross; Bonus/Equity: Not specified; Benefits: Statutory benefits, private healthcare, additional paid days off, life insurance, private pension plan, fully paid parental leave & care of family member leave

Skills & Requirements

Must-have

  • Oncology asset medical writing strategy
  • Clinical regulatory medical writing
  • Authoring global oncology submissions
  • Leading multi-disciplinary matrix teams
  • Managing external medical writing vendors
  • Program management and risk identification

Nice-to-have

  • Collaborative leadership style
  • Practical problem solving
  • Inclusive coaching for teams
  • 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/leading oncology FDA/EMA submissions
  • Experience leading matrix teams and vendors
  • Program management skills
  • Strong written and verbal communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter