Serve 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.
May assist with more complex clinical and scientific program level documents, including IBs, INDs, and MAAs.
Ensure 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.
Represent the department at project launch meetings, review meetings, and project team meetings.

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).
Experience working in the pharmaceutical/CRO industry preferred
Experience in scientific writing advantageous
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
Good knowledge of regulatory documentation and drug development process
Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

FSP Medical Writer

About this role