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 is 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 or guiding junior medical writers.
Requirements include:
* Experience as a medical writer, especially in Phase I - III protocols and CSR writing
* Stakeholder management skills, both 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]. We can arrange a confidential discussion about this exciting opportunity.
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