Lead/ Senior Medical Writer
Remote (UK, Ireland, Italy, Sweden, Spain)
£50,000 - £75,000
Lead Medical Writer opportunity working for a cutting edge Oncology focused global clinical research organisation conducting early- and late-phase oncology trials in the US, Europe, and Asia.
As a Lead Medical Writer, you will manage and support them with Regulatory and Clinical writing. You will be responsible for the preparation of clinical regulatory documentation for regulatory submissions, writing clinical documents e.g. IBs, CSRs, clinical overviews, module 2 clinical summaries, paediatric plans, orphan designation applications and regulatory briefing documents.
Responsibilities
• Initial Investigational New Drug (IND) applications and amendments
• Clinical study protocols and protocol amendments
• Investigator's brochures and updates
• Interim and final clinical study reports
• IND annual reports
• Development safety update reports
Requirements
• Multiple years working in a medical writing position. 5+ years prior experience in a CRO/pharmaceutical environment
• Lead writer experience on multiple documents
• Bachelor’s degree required / Advanced degree preferred
This is an excellent opportunity to gain further exposure in Medical Writing, acting as a senior figure within a cutting-edge oncology business. This position will be reporting to the VP of clinical development. This role can be a fully remote position across Europe and comes with an attractive package and a number of career development opportunities.
If you are interested in this role or would like more details please email your CV to [email protected]
Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.