The Medical Writing Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio.
The Assistant Narrative Medical Writer is responsible for the development of medical writing deliverables for a limited set of documents within a single therapeutic area under the supervision of management and Principal Medical Writer Safety Lead.
The MW supports the clinical development pipeline through scientific contribution of clinical documents related to safety.
The MW delivers quality English language documents in compliance with internal conventions and industry standards in a timely and efficient manner following the department and company processes and tools.
The Assistant Narrative Medical Writer will also participate in :
Training for the development of writing skills in support of safety reporting for regulatory documents
Process improvement activities (ie, maintenance of guidance documents, UAT)
Data collection for document metrics as defined by the process
Exposure to CSR (Clinical Study Report) methodology and trial information content, IB updates with opportunities for practice
Additional therapeutic area exposure
Qualifications, Skills & Experience
Degree in a life science, preferably related to pharmacy or medicine
Bachelor’s degree with 2+ years; MS with 1+ year; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with
The Assistant Narrative Medical Writer must demonstrate the following skills :
Complete fluency in reading and writing American English
Writing and editing skills following defined processes and templates
Ability to develop cohesive and concise text to report safety information to regulatory agencies
Ability to evaluate data and apply scientific knowledge to support the safety reporting in drug development
Ability to search databases to obtain and identify data required for developing the safety narrative
Detailed oriented with a focus on delivering quality document
Knowledge of systems used for collaborative authoring and document workflow (ie document management systems, SharePoint)