Medical Writer

CK Clinical are recruiting for a Medical Writer to join a well-established, global CRO, based from their site in West Sussex.

Salary: Base salary up to £50,000 per annum.

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.
• A PhD or MSc in Biology or health-related science is desirable and proven 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 guidances, drug development processes
• Excellent written and verbal skills

Apply: 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 smaccioni@ckclinical.co.uk. Please quote reference 49633 in all correspondence.