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

JR United Kingdom; Derby; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading global clinical research organization is seeking a Senior Medical Writer based in the UK. The role involves authoring complex clinical documents, managing projects, and supervising junior writers. Ideal candidates should have experience in medical writing and project management, contributing to critical regulatory submissions for diverse therapeutic areas.

Qualifications

• Experience as a medical writer with high-complexity documents.
• Experience leading medical writing projects.
• Familiarity with Phase I-III protocol and CSR.

Responsibilities

• Author high-complexity clinical documents including protocols and investigator brochures.
• Lead multiple projects and supervise junior medical writers.
• Prepare clinical evaluation plans and CTD/eCTD format documents.

Skills

Stakeholder Management

Project Management

Job description

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

Planet Pharma is 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 author 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 the chance to join a renowned CRO and contribute to bringing therapies to market across various therapeutic areas. You will be assigned to one sponsor, lead multiple projects, and supervise junior medical writers.

Ideal candidates will have experience as a medical writer, project lead on medical writing projects, and with:

• Phase I - III protocol and CSR medical writing
• Stakeholder management (internal and external)
• Project management skills

For more information, contact Chanel Hicken at 0203 868 1011 or email your CV to [emailprotected] for a confidential discussion about this opportunity.