CK Clinical are recruiting for a Medical Writer to join a well-established, global CRO who are based in London.
Responsibilities:
- 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.
Your Background:
- 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
Apply:
Entitlement to work in the UK is essential.
Please quote reference 50138 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Stephanie Maccioni
- Phone: 01438 743047
- Reference: 50138
Website: CK Group
- Posted: 7th April 2021
- Expires: 5th May 2021
