CK Clinical are recruiting for a Medical Writer to join a well-established, global CRO who are based in London.
- Investigational Medicinal Product Dossiers (IMPDs)
- Clinical Trial Applications and amendments
- Clinical studyprotocols and protocol amendments
- Investigator brochures and updates
- Interim and final clinical study reports
- Development Safety Update Reports
- Patient Informed Consent Forms
- Scientific Advice Briefing documents
- Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents.
- Minimum of a BA/BS in Science. Advanced degree in a health-related science is desirable.
- Familiarity with industry principles of drug safety, EU and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
- Knowledge of ICH guidelines, drug regulation guidances, drug development processes
- Excellent written and verbal skills
Entitlement to work in the UK is essential. For more information or to apply for this Medical Writer position, please contact Stephanie Maccioni on 01438 768713 or email firstname.lastname@example.org. Please quote reference 50138 in all correspondence.