My Client are a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Their mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. My Client are looking to take someone on a Permanent & Full Time position and will require someone to site 1 day a week.
- Investigational Medicinal Product Dossiers (IMPDs)
- Clinical Trial Applications and amendments
- Clinical study protocols 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.
- A PhD or MSc in Biology or health-related science is desirable and minimum 2 years of experience in pharmaceutical medical writing is preferred.
- 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 guidance's, drug development processes
- Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook)
If you are interested in this role please contact me on 0203 88 77 365 or email at #removed#