Education and Experience Requirements: BASE (level 1)
• Advanced degree in a relevant scientific/clinical/regulatory field. At least 5 years of pharmaceutical medical writing experience inclusive of clinical study documents and global clinical regulatory submissions.
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
• Knowledge of current requirements and guidelines applicable to submission documents.
• Excellent writing skills.
• Excellent interpersonal and oral communication skills.
• Strong knowledge of MS Word and Outlook, some knowledge of Excel and PowerPoint.
• Project management and organizational skills required including ability to manage timelines and prioritize multiple projects.
ADVANCED (level 2), in addition to BASE
• At least 10 years of regulatory medical writing experience in the pharmaceutical industry.
• Extensive authoring experience across multiple TAs in both early and late development programs.
• Experience authoring Health Authority responses is required.
• Strong project management skills required.