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

JR United Kingdom; Newcastle upon Tyne; Remote; GBP 45,000 - 70,000; Full time

Job summary

A global clinical research organisation is seeking a Senior Medical Writer for a home-based role in the UK. The successful candidate will lead projects, author complex clinical documents, and supervise junior writers while contributing to bringing key therapies to market.

Qualifications

• Experience as a medical writer, particularly in project leadership roles.
• Phase I - III protocol and CSR medical writing experience.
• Strong stakeholder management skills (internal and external).

Responsibilities

• Author high-complexity study-level documents including protocols and investigator brochures.
• Independently author clinical evaluation plans and reports.
• Supervise junior medical writers and lead multiple projects.

Skills

Project management

Stakeholder management

Leadership

Job description

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.