Work Schedule

Environmental Conditions

Job Description

• Serves as primary author who writes and provides input on routine documents 
such as clinical study reports and study protocols, and summarizes data from 
clinical studies.
• Ensures compliance with quality processes and requirements for assigned 
documents. May assist in determining best practices, methods and techniques 
for achieving optimal results.
• May assist in program management activities. Duties could include assisting with 
developing timelines, budgets, forecasts for assigned deliverables. 
• Represents the department at project launch meetings, review meetings, and 
project team meetings.

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational Qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Knowledge, Skills and Abilities:

• Solid medical writing skills, including grammatical, editorial, and proofreading skills

• Ability to interpret and present complex data accurately and concisely

• Effective administrative, organizational and planning skills; attention to detail and quality

• Ability to work on own initiative and effectively within a team

• Effective oral and written communication skills

• Good knowledge of regulatory documentation and drug development process