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