Reference Number: JO-1909-437548
Senior Medical Writer
Job Type: Permanent
Location: United States
CPL Physicians is working with a world leading neuroscience business based near New York City which has active programs in epilepsy, MS, Parkinson’s and Alzheimers’. They require an experience Senior Manager, Medical Writing.
The Senior Manager, Medical Writing will work on 3-4 Neuroscience Programs. As the Lead Medical Writer will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.
– Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead
– Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material
– Routinely engaging clinical research and biostatistics to gain comprehensive understanding of study design, objectives and results
– Providing guidance to other medical writers applying industry and medical writing best practices
– With minimal supervision, preparing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports
– Contributing to the writing of marketing application submission documents
An advanced life science degree
Experience in neuroscience medical writing
Experience of regulatory submission preparation is essential.
This is a well compensated permanent role with good bonus and ltip and benefits. For more information please CLICK APPLY and forward a resume.