Clinical Writer Specialist

6 dni temu


Warszawa, Mazovia, Polska GSK Pełny etat
About the Role

We are seeking a highly skilled Senior Medical Writer to join our team. As a Senior Medical Writer, you will be responsible for creating high-quality written content for clinical trials and regulatory documents.

Key Responsibilities:

  • Create a range of clinical documents, including protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
  • Evaluate data interpretation with the document team to ensure accuracy and integrity.
  • Maintain consistency and quality level of all issued documents.
  • Participate in planning, coordination, and review meetings to ensure seamless delivery of writing assignments.
Requirements

To be successful in this role, you will need:

  • A PhD or equivalent expertise (e.g., a master's degree with a minimum of 2 years' relevant experience).
  • Up to 5 years of clinical regulatory writing experience in the pharmaceutical industry.
  • A good understanding of basic drug development.
  • Knowledge of scientific methodology and statistical principles in the design, conduct, and description of clinical research.
  • Understanding of how to interpret, describe, and document clinical data.
  • Working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
  • Strong IT skills.
  • Excellent English language skills (verbal and written).


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