Regulatory Medical Writer
|Job Title:||Regulatory Medical Writer|
|Contact Name:||Alex Young|
|Job Published:||April 12, 2017 08:41|
As well as a strong 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 PhD 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 proven ability to meet deadlines and be results-oriented. Ability to manage critical issues on multiple projects simultaneously is key. 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 (MS Word is required).
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