CK Clinical are recruiting for a Medical Writer to join a well-established, global CRO who are based in London.
Medical Writer Role:
- Investigational Medicinal Product Dossiers (IMPDs).
- Clinical Trial Applications and amendments.
- Clinicalstudy 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.
- Provideguidance 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 guidance’s, drug development processes.
- Excellent written and verbal skills.
Apply: For more information or to apply for this Medical Writer position, please contact Stephanie Maccioni on 01438 768713 or email firstname.lastname@example.org, quoting job ref 50138.
It is essential that applicants hold entitlement to work in the UK.