Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £38000 - £65000
Job Status: Permanent / Full Time
My client is urgently seeking a Senior Regulatory Medical Writer- Oncology/Immunology
(Flexibility on being homebased will depend on experience but will need to be at least 2 days in the office.)
The successful candidate will be a motivated individual with a science, research, publishing and medical writing background who would like the opportunity to help us build our medical writing team and be involved in the development of new products being evaluated for the treatment of cancer.
As well as a keen interest in medical writing, the ideal applicant will also have the ambition to develop their project management capabilities.
Job responsibilities include but are not limited to the preparation of:
• Clinical study protocols and protocol amendments
• Investigational Medicinal Products Dossiers
• Clinical Trial Applications and amendments
• Interim and final reports for clinical studies
• Annual study reports
• Investigator brochures
• Patient Informed Consent forms
A Ph.D. or MSc in Biochemistry, Immunology, Biology or a health-related science is desirable. Some familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology, and oncology would be advantageous although not mandatory. The position requires a proven ability to meet deadlines and be results-oriented. Ability to manage critical issues on multiple projects simultaneously is vital. The person in this capacity will be a team player, highly organized, self-motivated, and extremely detail-oriented. He/she will have strong oral and written communication skills, excellent interpersonal skills, and advanced computer literacy (Extensive knowledge of MS Word is required).