Senior Medical Writer - Global Clinical Research Organisation - Home based in UK

JR United Kingdom; Chester; Remote; GBP 45,000 - 70,000; Full time

Job summary

A leading global clinical research organisation is seeking a Senior Medical Writer to work from home based in Chester, UK. This role involves authoring complex clinical documents and leading projects while supervising junior writers. The ideal candidate will have experience in medical writing across various phases and strong project management skills.

Qualifications

• Experience as a medical writer and project lead on medical writing projects.
• Experience with Phase I - III protocol and CSR medical writing.

Responsibilities

• Author high-complexity study-level documents including protocols and ICFs.
• Independently author clinical evaluation plans and reports.

Skills

Project management

Stakeholder management

Leadership

Job description

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Senior Medical Writer - Global Clinical Research Organisation - Home based in UK, Chester

Planet Pharma is currently working with a global clinical research organisation (CRO) that is looking for an experienced Medical Writer to join the team and 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 be responsible for independently authoring:

• Clinical evaluation plans and clinical evaluation 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 significant role in bringing key therapies to market across various therapeutic areas. You will be assigned to one sponsor, leading multiple projects, and supervising and guiding junior medical writers.

For this position, the client is seeking someone with experience as a medical writer and project lead on medical writing projects.

You should also have experience with:

• Phase I - III protocol and CSR medical writing
• Stakeholder management, both internal and external
• Project management and leadership skills

For more information on this position or similar opportunities, please contact Chanel Hicken at 0203 868 1011 or email your updated CV to [email protected], and we can arrange a confidential discussion about this exciting opportunity.