Clinical Writer Specialist
6 dni temu
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.
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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