Senior Medical Writer - Global Clinical Research Organisation - Home based in UK
Planet Pharma is currently working with a global clinical research organisation (CRO) seeking an experienced Medical Writer to support the preparation of submission and other complex clinical documents.
As a Senior Medical Writer, you will be responsible for authoring high-complexity study-level documents including protocols, ICFs, investigator brochures, and meeting packages. You will also independently author:
* Clinical evaluation plans and reports
* Paediatric Investigational Plans (PIPs)
* Clinical summaries and overview documents in CTD/eCTD formats for global regulatory submissions
This role offers an exciting opportunity to join a renowned CRO and contribute to bringing key therapies to market across various therapeutic areas. You will be assigned to one sponsor, leading multiple projects, and supervising junior medical writers.
Ideal candidates will have experience as a medical writer, particularly in project leadership roles, with:
* Phase I - III protocol and CSR medical writing experience
* Stakeholder management skills (internal and external)
* Project management and leadership abilities
For more information, please contact Chanel Hicken at 0203 868 1011 or email your updated CV to [emailprotected] for a confidential discussion about this opportunity.
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