Job Description:
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- 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, and 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.
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