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).
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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