Senior Medical Writer - Global Clinical Research Organisation - Home based in UK
Planet Pharma is currently working with a global clinical research organisation (CRO) who is looking for an experienced Medical Writer to join the team and support with the preparation of submission and other complex clinical documents.
As 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 be responsible for independently authoring:
* Clinical evaluation plans and Clinical evaluations reports
* Paediatric Investigational Plans (PIPs)
* Clinical summary and overview documents in CTD/eCTD formats for global regulatory submissions
This is an exciting opportunity to join a globally renowned CRO and play a big part in bringing key therapies to market across a variety of therapeutic areas. You will be assigned to one sponsor and you will be leading on multiple projects, as well as supervising and providing guidance to more junior medical writers.
For this position, my client is looking for someone who has experience as a medical writer and has experience working as project lead on medical writing projects.
You will also have experience with:
* Phase I - III protocol and CSR medical writing experience
* Stakeholder management - both internal and external
* Project management/project lead skills
For more information on this position or any similar opportunities, please contact Chanel Hicken on 0203 868 1011 or email your updated CV to chanel.hicken@planet-pharma.co.uk and we can arrange a time for a confidential discussion on how you can get involved in this exciting opportunity.