Description:
We’re looking for a seasoned medial writer with medical regulatory writing experience, who is a “Superstar,” with the following experience:
- CERs
- Briefing Books
- Investigator brochures
- Study protocols
- Informed consent documents
- Clinical study reports
- Safety updates
- Integrated summaries of safety and efficacy
- Study manuals, monitoring guidelines
- Papers and manuscripts
Requirements:
- Advanced degree in life sciences or medical field or a Bachelor’s degree from a top undergraduate institution
- Knowledge of or aptitude for understanding medicine; familiarity with the drug development process and regulatory documentation.
- Understand drug development including the various trial phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
- Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production.
- Must be able to gather and synthesize large amounts of data.
- Attention to detail and produces accurate work, even when under pressure; check the accuracy of information before using it or passing it on to others.
- Demonstrated ability to accurately edit clinical documents.
- Understand the role of various documents relevant to drug development in an international environment.
- Proficient computer skills, with applications such as MS Office that include Word, PowerPoint, and Outlook. Competency in a software application for managing references
To Apply:
Please send your resume, in Microsoft Word format, to [email protected].
