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

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

Job summary

A global clinical research organisation is seeking a Senior Medical Writer to prepare complex clinical documents including protocols and evaluation plans. This home-based role in the UK offers the chance to join a renowned CRO, guiding junior writers and leading multiple projects for a single sponsor.

Qualifications

• Experience as a medical writer with leading medical writing projects.
• Protocol and CSR medical writing for Phases I-III is essential.

Responsibilities

• Authoring high-complexity study-level documents including protocols and investigator brochures.
• Independently authoring clinical evaluation plans and reports.

Skills

Stakeholder management

Project management

Leadership skills

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) that is looking for an experienced Medical Writer to join their team. The role involves supporting 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 position offers the 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.

The ideal candidate will have experience as a medical writer and have led medical writing projects.

Required experience includes:

• Protocol and CSR medical writing for Phases I-III
• Stakeholder management (internal and external)
• Project management and leadership skills

For more information or to apply, 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.