Responsibilities:
- Serve as the primary author, writing and providing input on routine documents such as clinical study reports and study protocols, and summarizing data from clinical studies.
- Ensure compliance with quality processes and requirements for assigned documents.
- Assist in determining best practices, methods, and techniques for achieving optimal results.
- Participate in program management activities, including developing timelines, budgets, and forecasts for assigned deliverables.
- Represent the department at project launch meetings, review meetings, and project team meetings.
Qualifications:
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 the drug development process.
