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Senior Medical Writer - Global Clinical Research Organisation - Home based in UK, Southampton
Planet Pharma is currently working with a global clinical research organisation (CRO) looking for an experienced Medical Writer to join their team and support with 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 summary and overview documents in CTD/eCTD formats for global regulatory submissions
This role offers the 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 or guiding junior medical writers.
Ideal candidates will have experience as a medical writer, with project leadership experience in medical writing projects.
Required experience includes:
* Phase I - III protocol and CSR medical writing
* Stakeholder management (internal and external)
* Project management and leadership skills
For more information, please contact Chanel Hicken at 0203 868 1011 or email your updated CV to [emailprotected] for a confidential discussion about this exciting opportunity.
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